Brief report

First human case of esophagus-tracheal fistula closure by using a cardiac septal occluder (with video)

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.

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.

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.

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.)

Iatrogenic perforation (IP) is a rare but severe complication of endoscopy, and occurrences grow with the expansion of interventional endoscopy. Apart from symptoms and physical signs, CT scans provide an immediate and comprehensive diagnosis of IP and its severity. The general treatment is broad-spectrum antibiotics, intravenous nutrition, and close monitoring. Endoscopic treatments are considered as the first-line therapy. Endoclips are usually utilized for small perforations, while endoclips with endoloops and over the scope clip system are preferred for large ones. Covered self-expandable metal stents are effective for esophageal perforations. Fibrin glue and band ligation can be attempted, when the location of perforation is difficult for the clip placement. Close observation is required after the procedure. If endoscopic closure fails or deterioration occurs, surgical treatments should be requested.

Full-thickness gastrointestinal (GI) defects remain a daunting clinical problem in modern medicine. They vary in size, location in the GI tract, etiology, and chronicity. While traditionally managed with surgical techniques or medical management, technological advancements have created a third management option (therapeutic endoscopy), which often result in definitive defect closure. With the advent of these endoscopic therapies, many centers have moved to endoscopic management as first-line therapy of such defects. Optimal endoscopic management may require multimodal, multisession therapy, which occurs in the setting of a multispecialty management team. This manuscript reviews the use of endoscopic clips (both through-the-scope and over-the-scope), endolumenal stents, endoscopic suturing, endolumenal vacuum devices, and other emerging technologies in the managing of full-thickness GI defects. We examine the optimal clinical application of each modality and review their limitations.

Esophagorespiratory fistulas (ERFs) are pathologic communications between the esophagus and respiratory tract. They are devastating conditions of malignant or benign (often iatrogenic) etiologies. Patients with ERF have significantly increased mortality and decreased quality of life. Multiple management options exist for the treatment of ERFs including surgical, endoscopic, and oncologic approaches. Surgical management, with fistula closure and removal of diseased esophageal or pulmonary tissue, is the time-honored treatment of ERF. However, these surgeries are major undertakings and many patients with ERF are poor surgical candidates. As such oncologic and endoscopic therapies are often employed. Many endoscopic therapies exist for the management of ERF and include: esophageal stenting, airway stenting, combined esophageal, and airway stenting, over-the-scope clip placement, cardiac septal occlusion devices, and other novel therapies (argon plasma coagulation, fibrin glue, endoscopic suturing, and polyglycolic acid sheets). These treatments can be employed alone or in combination. Each endoscopic management strategy has its own clinical success rate and adverse events. Although advances in endoscopic techniques have broadened the tools available to treat ERFs; little if any data are available comparing the various endoscopic management strategies. Despite this an experienced clinician may select the appropriate intervention to maximize the risks/benefits of the procedure based on the size, location, and etiology of the fistula.