Background and Aims
Upper GI–tracheobronchial fistula is a morbid condition with high mortality. It is
a challenge for endoscopists because currently available treatments have severe limitations.
In this study we assessed the efficacy and safety of an occluder we invented for endoscopic
closure of refractory upper GI–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. Secondary efficacy endpoints were technical success rates,
CSRs and CCRs at 1 and 6 months, near-complete closure rates, 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 men) were enrolled. Eighteen through-the-scope
occluders (TTSOs) and 10 through-the-overtube occluders (TTOOs) were implanted, with
a technical success rate of 100%. The mean procedure time for the TTSO and TTOO groups
were 28.0 ± 8.0 minutes and 31.8 ± 7.7 minutes, respectively. The CSRs at 1, 3, and
6 months were 92.9%, 96.4%, and 92.0% and the CCRs were 60.7%, 60.7%, and 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 < .05). Two completely occluded fistulas had 1-sided or complete healing by coverage
of granulation tissue and re-epithelialized mucosa at a follow-up of 6 and 12 months.
All 14 adverse events were either mild and transient or easily corrected.
Conclusions
Our clinical outcomes suggest that this novel GI occluder is a safe and effective
salvage option for patients with refractory upper GI–tracheobronchial fistulas. (Clinical
trial registration number: ChiCTR2000038566.)
Abbreviations:
AE (adverse event), BMI (body mass index), CCR (complete closure rate), CSO (cardiac septal occluder), CSR (clinical success rate), HRQoL (health-related quality of life), IQR (interquartile range), NCR (near-complete closure rate), TEF (tracheoesophageal fistula), TTOO (through-the-overtube occluder), TTSO (through-the-scope occluder)To read this article in full you will need to make a payment
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Article info
Publication history
Published online: December 23, 2022
Accepted:
December 18,
2022
Received:
September 11,
2022
Publication stage
In Press Journal Pre-ProofFootnotes
DISCLOSURE: All authors disclosed no financial relationships. Research support (G.Z.) for this study was provided by the National Natural Science Foundation of China (no. 81970499) and the Key Project for Social Development in Jiangsu Province of China (no. BE2020784).
Identification
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© 2022 by the American Society for Gastrointestinal Endoscopy
