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Abstract
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.
Methods
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.
Results
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.
Conclusion
Our clinical outcomes suggest that this novel gastrointestinal occluder is a safe
and effective salvage option for patients with refractory upper gastrointestinal-tracheobronchial
fistulas.
Keywords
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)To read this article in full you will need to make a payment
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Article info
Publication history
Accepted:
December 18,
2022
Received in revised form:
November 19,
2022
Received:
September 11,
2022
Publication stage
In Press Journal Pre-ProofFootnotes
Funding support: This study was funded by National Natural Science Foundation of China (No. 81970499) and the Key Project for Social Development in Jiangsu Province of China (No. BE2020784).
Conflict of interest: All authors disclosed no conflicts of interest.
Author Contributions:
Conception and design: Guoxin Zhang, Jianyu Wei, Lurong Li, Chang Zhu, Huaiming Sang;
Endoscopic procedure: Guoxin Zhang, Jiwang Wang, Lurong Li, Yun Wang, Weifeng Zhang, Shuxian Jin, Yu Jin, Wangjian Zha, Wei Song, Yi Zhu;
Data collection: Chang Zhu, Lurong Li, Miao Xu, Jiahao Liu;
Data analysis and interpretation: Lurong Li, Han Chen, Haisheng Qian;
Drafting of the article: Lurong Li;
Critical revision of the article: Simon K. Lo, Guoxin Zhang;
Final approval of the article: All authors.
Our trial was registered in Chinese Clinical Trial Register, ChiCTR2000038566 on September 24, 2020.
Identification
Copyright
© 2022 by the American Society for Gastrointestinal Endoscopy
