Safety and efficacy of over-the-scope clips versus standard therapy for high-risk nonvariceal upper GI bleeding: systematic review and meta-analysis

      Background and Aims

      Upper GI bleeding (UGIB) is a common condition associated with significant morbidity and mortality. Endoscopic hemostasis remains the mainstay of therapy and is mainly aimed at effective hemostasis and prevention of rebleeding. Lesions with high-risk stigmata can have rebleeding rates of as high as 26.3%. Rebleeding is associated with increased mortality and reduced success rates of endoscopic retreatment. The over-the-scope-clip (OTSC) is a device with widespread endoscopic indications including hemostasis for nonvariceal UGIB (NVUGIB). The current study presents a systematic review and meta-analysis comparing OTSCs versus standard therapy (STD) for NVUGIB.

      Methods

      Multiple databases were searched through April 2022 for studies comparing OTSCs and STD for NVUGIBs. Primary outcomes were clinical success rates, rebleeding rates, and procedure times, and secondary outcomes were mortality rates and length of hospitalization. Meta-analysis was performed to determine pooled odds ratios to compare outcomes between the OTSC and STD groups.

      Results

      Ten studies, including 4 randomized controlled trials, with 914 patients were included in the final analysis. Of patients with NVUGIB, 431 were treated with OTSCs and 483 with STD. Patients treated with OTSCs had an overall lower risk of 7-day (risk ratio [RR], .41; 95% confidence interval [CI], .24-.68; I2 = 0%) and 30-day rebleeding (RR, .46; 95% CI, .31-.65; I2 = 0%). Clinical success rates were higher with OTSCs compared with STD (RR, 1.36; 95% CI, 1.06-1.75). Mean procedure time was shorter in the OTSC group by 6.62 minutes (95% CI, 2.58-10.67) versus the STD group (I2 = 84%). There was no statistically significant difference in terms of mortality between the OTSC and STD groups (RR, .55; 95% CI, .24-1.24; I2 = 0%). Length of hospitalization was comparable between both groups, with a pooled mean difference for OTSCs versus STD of .87 days (95% CI, –1.62 to 3.36 days; I2 = 71%).

      Conclusions

      Although our study was limited to high-risk NVUGIB, our analysis showed that hemostasis with OTSCs is associated with a lower 7-day and 30-day rebleeding rates, higher clinical success rates, and shorter procedure time with similar mortality rates and length of hospital stay as compared with STD.

      Graphical abstract

      Abbreviations:

      CI (confidence interval), NVUGIB (nonvariceal upper GI bleeding), OTSC (over-the-scope clip), RCT (randomized controlled trial), RR (risk ratio), STD (standard therapy), UGIB (upper GI bleeding)
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Gastrointestinal Endoscopy
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Wuerth B.A.
        • Rockey D.C.
        Changing epidemiology of upper gastrointestinal hemorrhage in the last decade: a nationwide analysis.
        Dig Dis Sci. 2018; 63: 1286-1293
        • Longstreth G.F.
        Epidemiology of hospitalization for acute upper gastrointestinal hemorrhage: a population-based study.
        Am J Gastroenterol. 1995; 90: 206-210
        • Hreinsson J.P.
        • Kalaitzakis E.
        • Gudmundsson S.
        • et al.
        Upper gastrointestinal bleeding: incidence, etiology and outcomes in a population-based setting.
        Scand J Gastroenterol. 2013; 48: 439-447
        • Laine L.
        • Barkun A.N.
        • Saltzman J.R.
        • et al.
        ACG Clinical guideline: upper gastrointestinal and ulcer bleeding.
        Am J Gastroenterol. 2021; 116: 899-917
        • Barkun A.N.
        • Almadi M.
        • Kuipers E.J.
        • et al.
        Management of nonvariceal upper gastrointestinal bleeding: guideline recommendations from the International Consensus Group.
        Ann Intern Med. 2019; 171: 805-822
        • Jensen D.M.
        • Kovacs T.O.G.
        • Ohning G.V.
        • et al.
        Doppler endoscopic probe monitoring of blood flow improves risk stratification and outcomes of patients with severe nonvariceal upper gastrointestinal hemorrhage.
        Gastroenterology. 2017; 152: 1310-1318
        • Elmunzer B.J.
        • Young S.D.
        • Inadomi J.M.
        • et al.
        Systematic review of the predictors of recurrent hemorrhage after endoscopic hemostatic therapy for bleeding peptic ulcers.
        Am J Gastroenterol. 2008; 103 (quiz 2633): 2625-2632
        • Lau J.Y.
        • Sung J.J.
        • Lam Y.H.
        • et al.
        Endoscopic retreatment compared with surgery in patients with recurrent bleeding after initial endoscopic control of bleeding ulcers.
        N Engl J Med. 1999; 340: 751-756
        • Camus M.
        • Jensen D.M.
        • Kovacs T.O.
        • et al.
        Independent risk factors of 30-day outcomes in 1264 patients with peptic ulcer bleeding in the USA: large ulcers do worse.
        Aliment Pharmacol Ther. 2016; 43: 1080-1089
        • Nykänen T.
        • Peltola E.
        • Kylänpää L.
        • et al.
        Bleeding gastric and duodenal ulcers: case-control study comparing angioembolization and surgery.
        Scand J Gastroenterol. 2017; 52: 523-530
        • Bartell N.
        • Bittner K.
        • Kaul V.
        • et al.
        Clinical efficacy of the over-the-scope clip device: a systematic review.
        World J Gastroenterol. 2020; 26: 3495-3516
        • Li P.
        • Ma B.
        • Gong S.
        • et al.
        Efficacy and safety of endoscopic full-thickness resection in the colon and rectum using an over-the-scope device: a meta-analysis.
        Surg Endosc. 2021; 35: 249-259
        • Gralnek I.M.
        • Dumonceau J.M.
        • Kuipers E.J.
        • et al.
        Diagnosis and management of nonvariceal upper gastrointestinal hemorrhage: European Society of Gastrointestinal Endoscopy (ESGE) guideline.
        Endoscopy. 2015; 47: a1-a46
        • Gralnek I.M.
        • Stanley A.J.
        • Morris A.J.
        • et al.
        Endoscopic diagnosis and management of nonvariceal upper gastrointestinal hemorrhage (NVUGIH): European Society of Gastrointestinal Endoscopy (ESGE) guideline—update 2021.
        Endoscopy. 2021; 53: 300-332
        • Chandrasekar V.T.
        • Desai M.
        • Aziz M.
        • et al.
        Efficacy and safety of over-the-scope clips for gastrointestinal bleeding: a systematic review and meta-analysis.
        Endoscopy. 2019; 51: 941-949
        • Ofosu A.
        • Ramai D.
        • John F.
        • et al.
        Over-the-scope-clips as primary and rescue therapy for non-variceal gastrointestinal bleeding: a systematic review and meta-analysis.
        Min Gastroenterol Diet. 2019; 65: 70-76
        • Stroup D.F.
        • Berlin J.A.
        • Morton S.C.
        • et al.
        Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group.
        JAMA. 2000; 283: 2008-2012
        • Stang A.
        Critical evaluation of the Newcastle-Ottawa scale for the assessment of the quality of nonrandomized studies in meta-analyses.
        Eur J Epidemiol. 2010; 25: 603-605
        • Atkins D.
        • Eccles M.
        • Flottorp S.
        • et al.
        Systems for grading the quality of evidence and the strength of recommendations I: critical appraisal of existing approaches The GRADE Working Group.
        BMC Health Serv Res. 2004; 22: 4-38
        • DerSimonian R.
        • Laird N.
        Meta-analysis in clinical trials.
        Control Clin Trials. 1986; 7: 177-188
        • Schwarzer G.
        Book review. Methods for Meta-analysis in Medical Research. Alex J. Sutton, Keith R. Abrams, David R. Jones, Trevor A. Sheldon and Fujian Song. Wiley, Chichester, U.K., 2000.
        Statist Med. 2003; 22: 112-114
        • Lee C.H.
        • Cook S.
        • Lee J.S.
        • et al.
        Comparison of two meta-analysis methods: inverse-variance-weighted average and weighted sum of z-scores.
        Genom Inform. 2016; 14: 173-180
        • Higgins J.P.T.
        • Thompson S.G.
        • Deeks J.J.
        • et al.
        Measuring inconsistency in meta-analyses.
        BMJ. 2003; 327: 557-560
        • Keen T.
        • Ochieng A.
        • Boger P.
        • et al.
        The Ovesco over the scope clip (OTSC) reduces gastrointestinal haemorrhage re-bleeding rates—first UK series [abstract].
        Gut. 2019; 68: A4
        • Rahman I.
        • Duarte P.
        • Hollingworth T.
        • et al.
        The Ovesco OTSC for acute upper gastrointestinal bleeding—a large propensity score-matched UK series [abstract].
        Gut. 2021; 70: A73
        • Jensen D.M.
        • Kovacs T.
        • Ghassemi K.A.
        • et al.
        Randomized controlled trial of over-the-scope clip as initial treatment of severe nonvariceal upper gastrointestinal bleeding.
        Clin Gastroenterol Hepatol. 2021; 19: 2315-2323
        • Chan S.M.
        • Pittayanon R.
        • Wang H.-P.
        • et al.
        The use of over-the-scope-clip (OTSC) versus standard therapy for the prevention of rebleeding in high risk peptic ulcers: a randomised controlled trial [abstract].
        Gastrointest Endosc. 2021; 93: AB340-1
        • Schmidt A.
        • Gölder S.
        • Goetz M.
        • et al.
        Over-the-scope clips are more effective than standard endoscopic therapy for patients with recurrent bleeding of peptic ulcers.
        Gastroenterology. 2018; 155: 674-686
        • Mangiafico S.
        • Pigò F.
        • Bertani H.
        • et al.
        Over-the-scope clip vs epinephrine with clip for first-line hemostasis in non-variceal upper gastrointestinal bleeding: a propensity score match analysis.
        Endosc Int Open. 2020; 8: E50-E58
        • Robles-Medranda C.
        • Oleas R.
        • Alcívar-Vásquez J.
        • et al.
        Over-the-scope clip system as a first-line therapy for high-risk bleeding peptic ulcers: a retrospective study.
        Surg Endosc. 2021; 35: 2198-2205
        • Buddam A.
        • Rao S.
        • Koppala J.
        • et al.
        Over-the-scope clip as first-line therapy for ulcers with high-risk bleeding stigmata is efficient compared to standard endoscopic therapy.
        Endosc Int Open. 2021; 9: E1530-E1535
        • Ermerak G.G.
        • Behary J.
        • Koo J.H.
        • et al.
        Over the scope clips for primary therapy of bleeding upper gastrointestinal ulcers: a retrospective case control study [abstract].
        Gastrointest Endosc. 2019; 89: AB488-9
        • Meier B.
        • Wannhoff A.
        • Denzer U.
        • et al.
        Over-the-scope-clips versus standard treatment in high-risk patients with acute non-variceal upper gastrointestinal bleeding: a randomised controlled trial (STING-2).
        Gut. 2022; 71: 1251-1258
        • Qiu J.
        • Xu J.
        • Zhang Y.
        • et al.
        Over-the-scope clip applications as first-line therapy in the treatment of upper non-variceal gastrointestinal bleeding, perforations, and fistulas.
        Front Med (Lausanne). 2022; 9: 753956
        • Mohan B.P.
        • Adler D.G.
        Heterogeneity in systematic review and meta-analysis: how to read between the numbers.
        Gastrointest Endosc. 2019; 89: 902-903
        • Liu J.J.
        • Saltzman J.R.
        Endoscopic hemostasis treatment: How should you perform it?.
        Can J Gastroenterol. 2009; 23: 481-483
        • Greenspoon J.
        • Barkun A.
        • Bardou M.
        • et al.
        Management of patients with nonvariceal upper gastrointestinal bleeding.
        Clin Gastroenterol Hepatol. 2012; 10: 234-239
        • Kirschniak A.
        • Kratt T.
        • Stüker D.
        • et al.
        A new endoscopic over-the-scope clip system for treatment of lesions and bleeding in the GI tract: first clinical experiences.
        Gastrointest Endosc. 2007; 66: 162-167
        • Marmo R.
        • Rotondano G.
        • Piscopo R.
        • et al.
        Dual therapy versus monotherapy in the endoscopic treatment of high-risk bleeding ulcers: a meta-analysis of controlled trials.
        Am J Gastroenterol. 2007; 102 (quiz 469): 279-289
        • Hozo S.P.
        • Djulbegovic B.
        • Hozo I.
        Estimating the mean and variance from the median, range, and the size of a sample.
        BMC Med Res Method. 2005; 5: 13