Endoscopic closure of refractory upper gastrointestinal-tracheobronchial fistulas with a novel occluder: a prospective, single-arm, single-center study

Published:December 23, 2022DOI:
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      Background and aims

      Upper gastrointestinal-tracheobronchial fistula is a morbid condition with high mortality. It is a challenge for endoscopists because currently available treatments have severe limitations. This study was to assess the efficacy and safety of an occluder we invented for endoscopic closure of refractory upper gastrointestinal-tracheobronchial fistulas.


      This was a prospective, single-arm, single-center trial conducted between September 2020 and March 2022. All patients undergoing occluder placement were eligible to enroll. The primary endpoints were clinical success rate (CSR) and complete closure rate (CCR) at 3 months and safety. The secondary efficacy endpoints included technical success rate, CSRs and CCRs at 1 and 6 months, near-complete closure rates (NCRs), the change from baseline in body mass index (BMI) and health-related quality of life (HRQoL) at 1, 3 and 6 months.


      Twenty-eight patients (mean age 63.2 years; 23 males) were enrolled. Eighteen through-the-scope occluders (TTSOs) and 10 through-the-overtube occluders (TTOOs) were implanted and the technical success rate was 100%. The mean procedure time for the TTSOs and TTOOs groups were 28.0±8.0 min and 31.8±7.7 min respectively. The CSRs at 1, 3 and 6 months were 92.9%, 96.4%, 92.0% and the CCRs were 60.7%, 60.7%, 60.0%, respectively. The mean BMI at 3 and 6 months and HRQoL at 1, 3 and 6 months were significantly increased compared with baseline (P <0.05). Two completely-occluded fistulas had one-sided or complete healing by coverage of granulation tissue and re-epithelialized mucosa at follow-up of 6 and 12 months. All 14 adverse events were either mild and transient or easily corrected.


      Our clinical outcomes suggest that this novel gastrointestinal occluder is a safe and effective salvage option for patients with refractory upper gastrointestinal-tracheobronchial fistulas.


      Acronyms and abbreviations:

      GI (Gastrointestinal), AE (adverse event), TTSC (through-the-scope clip), OTSC (over-the-scope clip), CSO (cardiac septal occluder), TEF (tracheoesophageal fistula), TTSO (through-the-scope occluder), TTOO (through-the-overtube occluder), NJ (naso-jejunal), BMI (body mass index), HRQoL (health-related quality of life), SF-36 (36-Item Short Form Health Survey), PF (hysical functioning), RP (role-physical), BP (bodily pain), GH (general health), VT (vitality), SF (social functioning), RE (role-emotional), MH (mental health), CSR (clinical success rate), CCR (complete closure rate), NCR (near-complete closure rate), SD (standard deviation), IQR (interquartile range), POH (postoperative hospitalization), ROC (receiver operating characteristic), CT (computed tomography), CI (confidence interval)
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