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Metal versus plastic stents for drainage of malignant biliary obstruction before primary surgical resection

Published:April 21, 2016DOI:https://doi.org/10.1016/j.gie.2016.04.018

      Background and Aims

      Preoperative biliary drainage (PBD) with stent placement has been commonly used for patients with malignant biliary obstruction. In PBD, the placement of fully covered self-expandable metal stents (FCSEMSs) may provide better patency duration and a lower incidence of cholangitis compared with plastic stents. We aimed to evaluate which type of stent showed better outcomes in PBD.

      Methods

      In this multicenter, prospective randomized trial, we compared PBD with FCSEMSs versus plastic stents in 86 patients with malignant biliary obstruction between January 2012 and December 2014. Patients with obstructive jaundice were randomly assigned to undergo PBD either with plastic stents or FCSEMS placement.

      Results

      Baseline characteristics were not significantly different between the 2 groups. Endoscopic stent placement was technically successful in all patients. Procedure-related adverse events were not significantly different between the 2 groups (plastic vs FCSEMS group; 16.3% vs 16.3%, P = 1.0). Reintervention was required in 16.3% of the plastic stent group and 14.0% of the FCSEMS group (P = .763). The interval to surgery after PBD (plastic vs FCSEMS group; 14.2 ± 8.3 vs 12.3 ± 6.9 days, P = .426) was not significantly different between groups. Surgery-related adverse events occurred in 43.6% of the plastic stent group and 40.0% of the FCSEMS group (P = .755).

      Conclusions

      In patients with resectable malignant biliary obstruction, the outcomes of PBD with plastic stents and FCSEMSs were similar. Considering the cost-effectiveness, PBD with plastic stents may be preferable to FCSEMS placement. (Clinical trial registration number: NCT01789502.)

      Abbreviations:

      AE (adverse event), CBD (common bile duct), FCSEMS (fully covered self-expandable metal stent), LN (lymph node), PBD (preoperative biliary drainage), PPPD (pylorus-preserving pancreaticoduodenectomy), PPS (prophylactic pancreatic stent), SD (standard deviation), SEMS (self-expandable metal stent)
      Malignant biliary obstruction can occur as a consequence of pancreas head cancer, common bile duct (CBD) cancer, ampulla of Vater cancer, or external compression secondary to lymph node (LN) metastasis.
      • Saxena P.
      • Kumbhari V.
      • Zein M.E.
      • et al.
      Preoperative biliary drainage.
      The severity of obstructive jaundice can be correlated with disturbances in coagulation, decreased hepatic function, and the development of cholangitis. In addition, cholestasis may have deleterious effects on the cardiovascular system and renal function.
      • Padillo F.J.
      • Cruz A.
      • Briceno J.
      • et al.
      Multivariate analysis of factors associated with renal dysfunction in patients with obstructive jaundice.
      • Son J.H.
      • Kim J.
      • Lee S.H.
      • et al.
      The optimal duration of preoperative biliary drainage for periampullary tumors that cause severe obstructive jaundice.
      Preoperative biliary drainage (PBD) has been advocated to reduce perioperative and postoperative morbidities.
      • Bonin E.A.
      • Baron T.H.
      Preoperative biliary stents in pancreatic cancer.
      The most common and accepted method for biliary drainage is endoscopic stent placement with plastic stents or self-expandable metal stents (SEMSs). However, endoscopic biliary drainage can significantly increase the likelihood of bacterial colonization, a major factor that can alter postsurgical outcomes.
      • Bonin E.A.
      • Baron T.H.
      Preoperative biliary stents in pancreatic cancer.
      Patency rates and occurrence of cholangitis may be dependent on the luminal diameter of the stent.
      • Saxena P.
      • Kumbhari V.
      • Zein M.E.
      • et al.
      Preoperative biliary drainage.
      Compared with plastic stents, SEMSs have a significantly wider diameter and show a longer patency duration.
      • Davids P.H.
      • Groen A.K.
      • Rauws E.A.
      • et al.
      Randomised trial of self-expanding metal stents versus polyethylene stents for distal malignant biliary obstruction.
      • Kaassis M.
      • Boyer J.
      • Dumas R.
      • et al.
      Plastic or metal stents for malignant stricture of the common bile duct? Results of a randomized prospective study.
      As a result, SEMSs with a relatively large diameter may be particularly useful for PBD, enabling rapid improvement of jaundice and reduction of adverse events (AEs), including cholangitis. Particularly, neoadjuvant therapy is increasingly used in borderline resectable and locally advanced tumors, which delays surgery. In this setting, PBD is likely to have a much greater advantage.
      Recently, a nonrandomized prospective cohort study compared the outcomes of PBD with fully covered self-expandable metal stents (FCSEMSs) and plastic stents.

      Tol JA, van Hooft JE, Timmer R, et al. Metal or plastic stents for preoperative biliary drainage in resectable pancreatic cancer. Gut. Epub 2015 Aug 25.

      This study showed that FCSEMSs were superior to plastic stents during preoperative biliary drainage because occlusion and stent exchange were rare in PBD with FCSEMSs. However, to date, no randomized study has prospectively compared the outcomes of PBD with plastic stents versus SEMSs. Therefore, we compared the outcomes of PBD with either plastic stents or SEMSs in patients with malignant biliary obstruction.

      Methods

      Participants

      This study was a multicenter prospective randomized trial. Patients were recruited at tertiary referral centers in South Korea between January 2012 and December 2014. Inclusion criteria were as follows: (1) age between 20 and 80 years; (2) periampullary cancer, including pancreas head cancer, CBD cancer, or ampulla of Vater cancer; (3) a serum bilirubin level greater than 5 mg/dL; and (4) no evidence of distance metastasis or major arterial invasion based on a CT scan and positron emission tomography analysis. Exclusion criteria were as follows: (1) age less than 20 years or greater than 80 years; (2) hilar bile duct stricture; (3) previous biliary drainage with ERCP or percutaneous transhepatic biliary drainage; (4) combined acute cholecystitis or obstructive pancreatitis; (5) a history of previous gastric surgery, including subtotal gastrectomy with Billroth-II anastomosis and total gastrectomy, which would preclude ERCP; or (6) patient refusal to provide informed consent.
      Patients who met the eligibility criteria were randomized to the plastic stent group or FCSEMS group using computer-generated allocation. Allocation sequences were concealed from all patients and participating investigators using sealed envelopes. Details about stent allocation were supplied to the endoscopists immediately before ERCP in each patient. The interval between the screening imaging test and randomization was 3 days or less. Patients who lost eligibility to undergo curative resection after ERCP because of major arterial invasion or distant metastases that were identified during an additional staging were included in the intention-to-treat analysis.
      All patients provided written informed consent. The medical ethics committee at each center approved the study protocol. All authors had access to the study data and reviewed and approved the final manuscript. The clinical trial registration number is NCT01789502.

      Outcomes

      The primary outcome measure of this study was the rate of PBD procedure-related AE that prompted an additional medical, endoscopic, or surgical intervention, and occurred between the PBD procedure and surgery. The secondary outcome measures included perioperative morbidity and mortality, and the reintervention rate to achieve a successful PBD.

      Preoperative biliary drainage

      ERCP was performed by attending endoscopists who were experienced in this procedure (S.S.L., T.J.S., and J.W.J.). ERCP was performed using a standard duodenoscope (TJF-260; Olympus Medical Systems, Tokyo, Japan) with the patient under conscious sedation with midazolam and meperidine. A single dose of prophylactic antibiotics with third-generation cephalosporin was administered at the start of the biliary drainage procedure. After biliary cannulation and obtaining a cholangiogram, a guidewire was passed through the stricture. Sphincterotomy was performed in all patients. Because uncovered metal stents could not be removed from the bile duct during surgery, FCSEMSs were used. A plastic stent or FCSEMS was placed across the papilla at least 2 cm below the bifurcation of the CBD. Proper placement of the stent was confirmed by fluoroscopy. The plastic stents (Cotton-Leung, Wilson-Cook Medical Corporation, Winston-Salem, NC) used were 5- to 9-cm long with a diameter of 10F and the FCSEMSs (BONA, Standard Sci Tech Inc, Seoul, South Korea) were 4- to 7-cm long, expanding to a diameter of 8 or 10 mm. While the patient was awaiting surgery, reintervention was performed if postprocedural cholangitis, stent occlusion, or post-ERCP pancreatitis related to the stent placement occurred.
      After the procedure, the patients were carefully monitored to detect symptoms or signs suggestive of PBD procedure-related AE. The patients were kept fasting and resumed their diet the next morning. A physical examination, a simple abdominal radiograph, and blood tests for complete blood count, liver function tests, and serum amylase/lipase were checked for AE the next day.

      Surgery

      All patients received perioperative antibiotics. The standard surgical procedure for resectable tumors was pylorus-preserving pancreaticoduodenectomy or bile duct resection, including regional LN dissection.
      • van der Gaag N.A.
      • Rauws E.A.
      • van Eijck C.H.
      • et al.
      Preoperative biliary drainage for cancer of the head of the pancreas.
      • Gouma D.J.
      • Nieveen van Dijkum E.J.
      • Obertop H.
      The standard diagnostic work-up and surgical treatment of pancreatic head tumours.
      If cancer invasion into the proximal duodenum or pylorus was suspected, a classic Whipple procedure was performed with resection of the distal stomach. LN dissection included the LN in the peripancreatic area, the common and proper hepatic artery, the hepaticoduodenal ligament, and the right lateral area of the superior mesenteric vessel. In cases of mid-CBD cancer, bile duct resection without pancreaticoduodenectomy was performed according to the surgeon’s decision regarding the achievement of tumor-free margins of the distal CBD. Biliary stents were removed during CBD resection. If metastasis, peritoneal seeding, or major arterial invasion were found during laparotomy, palliative surgery consisting of the creation of a Roux-en-Y hepaticojejunostomy was performed. Perioperative morbidity within 30 days after surgery was recorded.

      Definitions

      The presence of cancer involvement in major arteries including the superior mesenteric artery and celiac axis, distant metastases, and peritoneal seeding were considered to indicate unresectability. Procedure-related AE included cholangitis, cholecystitis, pancreatitis, bleeding, or bowel perforation. Stent occlusion and stent migration that occurred before surgery were included in the procedure-related AEs.
      Acute cholangitis and cholecystitis were diagnosed using the Tokyo Guidelines 2013.
      • Kiriyama S.
      • Takada T.
      • Strasberg S.M.
      • et al.
      New diagnostic criteria and severity assessment of acute cholangitis in revised Tokyo Guidelines.
      • Yokoe M.
      • Takada T.
      • Strasberg S.M.
      • et al.
      TG13 diagnostic criteria and severity grading of acute cholecystitis (with videos).
      Stent occlusion was defined as persistent hyperbilirubinemia (<50% reduction in serum bilirubin levels after successful stent placement), which then required further intervention. Acute pancreatitis was defined as abdominal pain and increased levels of pancreatic enzymes (amylase or lipase) ≥3-fold greater than the upper normal limit. Bleeding was defined as clinical evidence of bleeding with the need for intervention or blood transfusion. Bowel perforation was defined as a retroperitoneal or bowel-wall perforation revealed by a radiographic image. Stent migration was defined as the distal or proximal displacement of the stent from the initial site.
      Curative resection was defined as a microscopically tumor-free resection margin after surgery and the complete removal of all metastatic LN. According to the International Study Group of Pancreatic Fistula, pancreatic fistula was diagnosed when there was measurable drain output on/after postoperative day 3, with an increased level of amylase ≥3-fold greater than the upper normal limit.
      • Bassi C.
      • Dervenis C.
      • Butturini G.
      • et al.
      Postoperative pancreatic fistula: an international study group (ISGPF) definition.
      Delayed gastric emptying (DGE) was defined as the need for maintenance of the nasogastric tube for 3 days, the need for reinsertion of the nasogastric tube for persistent vomiting after postoperative day 3, or inability to tolerate a solid diet by postoperative day 7.
      • Wente M.N.
      • Bassi C.
      • Dervenis C.
      • et al.
      Delayed gastric emptying (DGE) after pancreatic surgery: a suggested definition by the International Study Group of Pancreatic Surgery (ISGPS).

      Statistical analysis

      Sample sizes were calculated based on a previously published study of PBD with plastic stents and SEMSs. Rates of stent-related AEs were 45% to 93% for plastic stents and 7% to 15% for SEMSs.
      • van der Gaag N.A.
      • Rauws E.A.
      • van Eijck C.H.
      • et al.
      Preoperative biliary drainage for cancer of the head of the pancreas.
      • Yoshida Y.
      • Ajiki T.
      • Ueno K.
      • et al.
      Preoperative bile replacement improves immune function for jaundiced patients treated with external biliary drainage.
      • Aadam A.A.
      • Evans D.B.
      • Khan A.
      • et al.
      Efficacy and safety of self-expandable metal stents for biliary decompression in patients receiving neoadjuvant therapy for pancreatic cancer: a prospective study.
      In our present trial, the expected AE rates after PBD were 50% in the plastic stent group and 20% in the FCSEMS group. The sample size that would be needed to detect a 30% difference in the AE rate between the 2 groups with a power of 0.81 and a significance level of 0.05 (α = 0.05, 2-sided) was calculated. Assuming a 10% dropout rate, the final sample size was determined to be 43 patients per group.
      The principal analysis consisted of an intention-to-treat comparison of the number of PBD-related AEs. We used descriptive analysis to document the demographic and clinical data of the patients. Continuous variables were presented as means with standard deviation and were analyzed using the Student t test. Differences in categoric variables were analyzed using the χ2 test and the Fisher exact test as appropriate. A P value <.05 was considered to denote a statistically significant difference. Statistical analysis was carried out using SPSS 21.0 (SPSS Inc, Chicago, Ill).

      Results

      Baseline characteristics

      The demographic and clinical characteristics of the study patients are summarized in Table 1. There were no significant differences in preoperative baseline characteristics including age, gender, body mass index, serum albumin, serum total bilirubin, or CA 19-9 at admission between the 2 groups. The most common type of tumor was pancreas head cancer in both groups, followed by CBD and ampulla of Vater cancer (P = .522).
      Table 1Demographics and clinical characteristics of the patients
      Plastic stent group (N = 43)FCSEMS group (N = 43)P value
      Age (years), mean ± SD65.72 ± 11.0665.67 ± 8.22.982
      Male:female25:1825:181.000
      Body mass index (kg/m2), mean ± SD23.0 ± 2.522.9 ± 2.7.817
      Albumin (mg/dL), mean ± SD3.29 ± 0.373.14 ± 0.48.128
      Initial total bilirubin (mg/dL), mean ± SD8.43 ± 3.979.29 ± 5.50.405
      Preoperative total bilirubin (mg/dL), mean ± SD1.40 ± 0.661.31 ± 0.68.579
      CA 19-9 (U/mL), mean ± SD391.5 ± 605.7291.1 ± 620.0.450
      Causes of obstructive jaundice, n (%).522
       Pancreatic cancer21 (48.8)26 (60.5)
       Common bile duct cancer13 (30.1)11 (25.5)
       Ampulla of Vater cancer9 (20.9)6 (14.0)
      FCSEMS, Fully covered self-expandable metal stent; SD, standard deviation.

      Preoperative biliary drainage-related outcomes

      ERCP with stent placement was technically successful in all patients. The duration from stent insertion to surgery was 14.2 ± 8.3 days in the plastic stent group and 12.3 ± 6.9 days in the FCSEMS group; these intervals were not significantly different between groups (P = .426). The rate of PBD procedure-related AEs was not significantly different between the 2 groups (plastic stent group vs FCSEMS group; 16.3% vs 16.3%, respectively, P = 1.000) (Table 2). The most common PBD procedure-related AE was stent occlusion without cholangitis (5 patients in the plastic stent group and 2 patients in the FCSEMS group), followed by post-ERCP pancreatitis (no case in the plastic stent group and 5 patients in the FCSEMS group) and cholangitis (2 patients in the plastic stent group and none in the FCSEMS group). Patients in whom PBD procedure-related AEs had occurred had longer duration from stent insertion to surgery (12.7 ± 7.5 days in patients without AEs vs 17.4 ± 7.8 days in patients with AEs, P < .05).
      Table 2Preoperative biliary drainage-related outcomes
      Plastic stent group (N = 43), nFCSEMS group (N = 43), nP value
      Stent length
       4 cm05
       5 cm1126
       6 cm010
       7 cm122
       8 cm60
       9 cm140
      PBD-related adverse events, n (%)7 (16.3)7 (16.3)1.000
       Pancreatitis05
       Stent occlusion without cholangitis52
       Cholangitis20
      Reintervention, n (%)7 (16.3)6 (14.0).763
       Plastic stent24
       Nasobiliary drainage31
       FCSEMS20
       Pancreatic stent01
      Interval to surgery after PBD (days), mean ± SD14.2 ± 8.312.3 ± 6.9.426
      FCSEMS, Fully covered self-expandable metal stent; PBD, preoperative biliary drainage; SD, standard deviation.
      Reintervention was required in 13 patients (7 patients in the plastic stent group and 6 patients in the FCSEMS group, P = .763) because of stent occlusion without cholangitis (n = 6), pancreatitis (n = 5), or cholangitis (n = 2). As reintervention procedures, we performed ERCP with plastic stent placement in 6 patients (2 in the plastic stent group and 4 in the FCSEMS group), ERCP with endoscopic nasobiliary drainage in 4 patients (3 in the plastic stent group and 1 in the FCSEMS group), ERCP with FCSEMS placement in 2 patients (2 in the plastic stent group), and ERCP with 5F pancreatic stent placement in 1 patient (1 in the FCSEMS group).

      Surgery-related outcomes

      A total of 12 patients (4 patients in the plastic stent group and 8 patients in the FCSEMS group) lost eligibility to undergo surgery after randomization and successful stent placement because of a diagnosis of metastasis (n = 4) or major arterial invasion (n = 2) before surgery, or refusal of surgery by the patient (n = 6; Fig. 1).
      Figure thumbnail gr1
      Figure 1Patient enrollment and group allocation.
      Seventy-four patients (86%) underwent surgery with curative intent; however, palliative bypass surgery was performed in 5 cases because local spread or metastasis was found at laparotomy. The rate of resection was 90.7% in the plastic stent group and 81.4% in the FCSEMS group; these rates were not significantly different (P = .600) (Table 3). Curative resection was achieved in 27 patients (69.2%) in the plastic stent group and 26 patients (74.3%) in the FCSEMS group (P = .630). There was 1 case of postoperative mortality in the plastic stent group that resulted from bowel ischemia. Surgery-related AEs occurred in 17 patients (43.6%) in the plastic stent group and in 14 patients (40.0%) in the FCSEMS group (P = .755), yielding a relative risk of 0.92 (95% confidence interval, 0.54-1.58) in the FCSEMS group.
      Table 3Surgical outcomes
      Plastic stent group (N = 39), n (%)FCSEMS group (N = 35), n (%)P value
      Pathologic tumor stage.619
       1/233 (84.6)31 (88.6)
       3/46 (15.4)4 (11.4)
      Histology.140
       Well differentiated7 (17.9)5 (14.3)
       Moderately differentiated21 (53.8)26 (74.3)
       Poorly differentiated11 (28.2)4 (11.4)
      Surgery.630
       PPPD29 (74.4)29 (82.9)
       Whipple operation2 (5.0)2 (5.6)
       Bile duct resection4 (10.3)3 (8.6)
       Palliative surgery4 (10.3)1 (2.9)
      Surgery-related adverse events17 (43.6)14 (40.0).755
       Pancreatic fistula33
       Grade A22
       Grade B11
       Grade C00
       Peripancreatic fluid collection74
       Wound infection24
       Hemoperitoneum11
       Delayed gastric emptying32
       Bowel ischemia10
      Mortality101.000
      Curative resection27 (69.2)26 (74.3).630
      FCSEMS, Fully covered self-expandable metal stent; PPPD, pylorus-preserving pancreaticoduodenectomy.

      Discussion

      To the best of our knowledge, this study is the first prospective randomized study comparing the outcomes of PBD with plastic stents and FCSEMS placement in patients with a resectable malignant biliary obstruction. It was designed to determine whether PBD with FCSEMSs was associated with fewer PBD procedures and surgery-related AEs compared with those for plastic stents in our routine clinical practice. We believed that the use of a FCSEMS with a wider lumen might somehow considerably change the outcome of PBD, as shown in previous retrospective studies that indicated its advantages in providing rapid biliary decompression and a significant reduction in preoperative reintervention rates compared with plastic stents.
      • Roque J.
      • Ho S.H.
      • Goh K.L.
      Preoperative drainage for malignant biliary strictures: is it time for self-expanding metallic stents?.
      However, the present study shows that the outcomes of PBD with plastic stents and FCSEMSs were not different in patients with malignant biliary obstruction who had planned to undergo early primary surgery.
      PBD was introduced to relieve the symptoms related to obstructive jaundice and to improve the postoperative outcomes of patients with obstructive jaundice caused by periampullary cancer.
      • van der Gaag N.A.
      • Rauws E.A.
      • van Eijck C.H.
      • et al.
      Preoperative biliary drainage for cancer of the head of the pancreas.
      Biliary obstruction resulting in hyperbilirubinemia can adversely affect hepatic and other organ system functions, and may also negatively affect the outcomes of major hepatobiliary surgery.
      • Bonin E.A.
      • Baron T.H.
      Preoperative biliary stents in pancreatic cancer.
      Whether or not patients with obstructive jaundice resulting from periampullary cancer require PBD was recently challenged. A recent prospective randomized study compared routine PBD with early surgery in patients with pancreatic cancer and concluded that routine PBD was associated with an increased incidence of AEs compared with early surgery without PBD.
      • van der Gaag N.A.
      • Rauws E.A.
      • van Eijck C.H.
      • et al.
      Preoperative biliary drainage for cancer of the head of the pancreas.
      In that study, 15% of patients had stent occlusion and 30% required stent exchange, which was higher than that of other reports. The PBD group in that study received plastic stent placement rather than SEMS placement, and the high rate of cholangitis and stent occlusion was attributed to the small-caliber plastic stents that were used. Given the poor results obtained using plastic stents, PBD might be best achieved with SEMS, which have been known to have a higher patency rate than plastic stents. Stents for biliary drainage have different patency rates that depend on their luminal diameter, so the choice of biliary stents might be regarded as a main factor for outcomes after PBD. Plastic stents can occlude because of the formation of bacterial biofilms and food materials, resulting in recurrent jaundice, frequently with cholangitis, and the need to repeat drainage procedures.
      • van Berkel A.M.
      • van Marle J.
      • Groen A.K.
      • et al.
      Mechanisms of biliary stent clogging: confocal laser scanning and scanning electron microscopy.
      Reobstruction of the stents with subsequent cholangitis is the most common problem that can jeopardize PBD.
      • Kitahata Y.
      • Kawai M.
      • Tani M.
      • et al.
      Preoperative cholangitis during biliary drainage increases the incidence of postoperative severe complications after pancreaticoduodenectomy.
      In a recent retrospective study that included 29 patients who underwent PBD for pancreatic cancer (18 plastic stents and 11 SEMSs), 39% of patients with plastic stent placement needed endoscopic reintervention before surgery, whereas none of the patients with SEMS placement required this procedure.
      • Decker C.
      • Christein J.D.
      • Phadnis M.A.
      • et al.
      Biliary metal stents are superior to plastic stents for preoperative biliary decompression in pancreatic cancer.
      The reasons for reintervention were cholangitis (n = 1) or persistent increased serum bilirubin level (n = 6). A study by Mullen et al
      • Mullen J.T.
      • Lee J.H.
      • Gomez H.F.
      • et al.
      Pancreaticoduodenectomy after placement of endobiliary metal stents.
      reported that stent patency was significantly greater in the SEMS group compared with the plastic stent group (125 vs 43 days, P < .001). Stent-related AEs, including stent occlusion, migration, or perforation, and stent exchange rate were significantly higher in the plastic stent group (45% vs 7%, P < .001).
      SEMSs have been associated with lower rates of reobstruction, cholangitis, and postoperative morbidity compared with small-caliber plastic stents, and they appear to be the preferred method for PBD when indicated.
      • Cavell L.K.
      • Allen P.J.
      • Vinoya C.
      • et al.
      Biliary self-expandable metal stents do not adversely affect pancreaticoduodenectomy.
      In the present study, the rate of cholangitis was not found to be significantly different between the groups. This finding might be attributable to the fact that the patients in this study underwent relatively early surgery in contrast to previous studies. The risk of cholangitis might increase in proportion to the period of stent placement. Because the duration between PBD and surgery was approximately 2 weeks in our study cohort, the rate of cholangitis in the plastic stent group might not be higher than anticipated. Currently, there are no guidelines for the optimal duration of biliary drainage.
      • Saxena P.
      • Kumbhari V.
      • Zein M.E.
      • et al.
      Preoperative biliary drainage.
      Son et al
      • Son J.H.
      • Kim J.
      • Lee S.H.
      • et al.
      The optimal duration of preoperative biliary drainage for periampullary tumors that cause severe obstructive jaundice.
      reported that PBD for >2 weeks had no beneficial effect on reducing morbidity or mortality. Notably, patients who could benefit from PBD with SEMS placement may include those in whom surgery is delayed (eg, for scheduling reasons or further preoperative staging), neoadjuvant chemotherapy is required, or whose underlying comorbidities require optimization or even improvement in nutritional status.
      • Saxena P.
      • Kumbhari V.
      • Zein M.E.
      • et al.
      Preoperative biliary drainage.
      Although several studies have shown that biliary drainage with SEMSs might result in a lower incidence of cholangitis and better patency duration, there has been a theoretical concern that the routine use of SEMSs for patients awaiting pancreaticoduodenectomy might lead to technical difficulties during surgery, resulting in an increased rate of postoperative morbidities.
      • Ayaru L.
      • Kurzawinski T.R.
      • Shankar A.
      • et al.
      Complications and diagnostic difficulties arising from biliary self-expanding metal stent insertion before definitive histological diagnosis.
      The incidence of surgical morbidities after FCSEMS placement in our study (40.0%) was similar to that in a recent study of early surgery without PBD (37.2%).
      • van der Gaag N.A.
      • Rauws E.A.
      • van Eijck C.H.
      • et al.
      Preoperative biliary drainage for cancer of the head of the pancreas.
      Other recent studies also indicated that SEMSs did not adversely affect surgical techniques, the postoperative course, or long-term outcomes. Properly placed SEMSs are not contraindications to surgery.
      • Lawrence C.
      • Howell D.A.
      • Conklin D.E.
      • et al.
      Delayed pancreaticoduodenectomy for cancer patients with prior ERCP-placed, nonforeshortening, self-expanding metal stents: a positive outcome.
      SEMSs placed below the biliary bifurcation do not pose technical challenges when carrying out surgical anastomosis.
      • Siddiqui A.A.
      • Mehendiratta V.
      • Loren D.
      • et al.
      Self-expanding metal stents (SEMS) for preoperative biliary decompression in patients with resectable and borderline-resectable pancreatic cancer: outcomes in 241 patients.
      The preoperative placement of a short-length SEMS (4-6 cm) has been reported to reduce the likelihood of stent occlusion without increasing perioperative morbidity or mortality.
      • Mullen J.T.
      • Lee J.H.
      • Gomez H.F.
      • et al.
      Pancreaticoduodenectomy after placement of endobiliary metal stents.
      We used the shortest possible FCSEMS and placed it at least 2 cm below the bifurcation of the bile duct to prevent difficulty in anastomosis. As a result, no specific difficulty occurred during surgery, and surgical outcomes were similar between the 2 groups.
      Contrary to the belief that SEMSs might yield better outcomes for PBD, our present findings showed that FCSEMSs did not decrease procedure-related AEs. In this study, the high rate of post-ERCP pancreatitis (11.6%) was the main reason for frequent PBD procedure-related AEs in the FCSEMS group. Both compression of the pancreatic duct orifice because of SEMS expansion and compression of the pancreatic duct because of the axial force of the SEMS can potentially lead to pancreatitis after SEMS placement.
      • Kawakubo K.
      • Isayama H.
      • Nakai Y.
      • et al.
      Risk factors for pancreatitis following transpapillary self-expandable metal stent placement.
      When pancreatic cancer obstructs the main pancreatic duct, particularly when it is accompanied by atrophy of the distal pancreatic parenchyma, pancreatic function is presumed to have already diminished, reducing the potential for pancreatitis after SEMS placement. For bile duct cancer, pancreatic function is often normal and the risk of developing pancreatitis after SEMS placement should be taken into account.
      • Okano N.
      • Igarashi Y.
      • Kishimoto Y.
      • et al.
      Necessity for endoscopic sphincterotomy for biliary stenting in cases of malignant biliary obstruction.
      When SEMS placement is required in patients with periampullary cancer who are undergoing surgery, prophylactic pancreatic stent (PPS) placement can be considered. PPS placement can prevent post-ERCP pancreatitis by maintaining the outflow of pancreatic juice.
      • Dumonceau J.M.
      • Andriulli A.
      • Deviere J.
      • et al.
      European Society of Gastrointestinal Endoscopy (ESGE) Guideline: prophylaxis of post-ERCP pancreatitis.
      Based on our current findings that FCSEMS placement may be related to the high risk of post-ERCP pancreatitis, we generally recommend using 10F plastic stents for PBD in patients with periampullary cancer who are undergoing surgery within 2 weeks. It appears sensible to restrict PBD with FCSEMS placement to selected instances of significant delay to definitive resection, or of planned preoperative induction chemotherapy. If FCSEMS is used, it may be critical to ensure that the stent is placed at least 2 cm below the bifurcation to allow for adequate biliary anastomosis, and the use of a small-caliber PPS might be recommended to prevent post-ERCP pancreatitis.
      • Saxena P.
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      • Zein M.E.
      • et al.
      Preoperative biliary drainage.
      • Dumonceau J.M.
      • Andriulli A.
      • Deviere J.
      • et al.
      European Society of Gastrointestinal Endoscopy (ESGE) Guideline: prophylaxis of post-ERCP pancreatitis.
      This study had several limitations of note. First, the interval from stent insertion to surgery was relatively shorter than that of previous retrospective studies. This study included only patients who were candidates for early primary surgery. Recently, neoadjuvant therapy, which delays surgery for 3 to 4 months, has been used more frequently, and PBD with FCSEMS placement may have a much greater advantage in this setting. Further prospective randomized studies that compare the outcomes of plastic stents and SEMSs in various clinical situations will be necessary. Second, we included relatively heterogeneous disease entities, including pancreatic cancer, CBD cancer, and ampulla of Vater cancer. However, only patients with periampullary cancer were evaluated, and obstructive jaundice, which necessitated biliary decompression, was a common feature.
      Plastic stents may be preferentially considered for biliary decompression while patients are awaiting early primary surgery. Based on the findings of the present study, PBD with FCSEMSs may not be advisable when early surgery is planned. However, further prospective randomized studies will be required to demonstrate the efficacy of FCSEMSs in PBD in diverse clinical settings.

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      Linked Article

      • Too short to choose biliary drainage?
        Gastrointestinal EndoscopyVol. 85Issue 3
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          We read the great interest the article by Song et al,1 “Metal versus plastic stents for drainage of malignant biliary obstruction before primary surgical resection.” The authors concluded that preoperative drainage with plastic stents is preferable to metal stent placement, considering the cost-effectiveness.
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