Closure of Anastomotic Leaks in the Stomach and Esophagus by Endoscopic Suturing

Study Overview
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Brief Summary
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Patients with suspected leakage at the specified surgical anastomoses undergo an immediate diagnostic endoscopy as part of current clinical routine. Consenting patients meeting the inclusion criteria will undergo closure of the defect by endoscopic suturing in addition to standard surgical care.

Official Title
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Safety and Efficacy of Closure of Postoperative Anastomotic Leaks in the Stomach and Esophagus by Endoscopic Suturing: A Prospective Pilot Study

Conditions
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Postoperative, Anastomosis, Surgical

Intervention / Treatment
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* Device: endoscopic suturing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: leakage at anastomosis within 2 weeks after upper gastrointestinal (GI) resection Exclusion Criteria: tubular ischemia of the upper GI tract inability to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: open label treatment arm<br>endoscopic suturing | Device: endoscopic suturing<br>* endoscopic suturing of the anastomotic leak<br>* Other names: FDA regulation number 21 CFR 876.1500, CE#: CE0123 (G2S 09 12 57666 029);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Endpoint to be recorded during hospital stay: Composite serious adverse event endpoint for 30 days after the diagnosis of anastomotic leakage including: Death Injury to vessels through the suture device, leading to bleeding or thrombosis Cardiac tamponade, arrhythmia Pneumothorax Bleeding requiring transfusion possible medium-term complications such as new mediastinal abscess | 2 years | 
| Technical feasibility | Technical success of the anastomotic closure | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to healing of the anastomotic leak | Scored during the hospital stay until 6 months after the original operation. Patients who die or undergo complete resection of the organ (e. g. esophagectomy with cervical fistula) are scored as nevel healed - i.e. censored events. Efficacy statistics need to use local historic controls and literature data. Statistical analysis will be performed using the LogRank test. | 2 years | 
| Long term safety | Long term safety Anastomotic stenosis, as assessed by endoscopy Clinically apparent functional problems (e.g. dysphagia, incontinence) | 6 months after diagnosis of anastomotic leakage | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgical leak, endoscopic suturing, Anastomotic leakage, esophageal or gastric resection