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

Not Applicable

• Conditions: Postoperative; Anastomosis, Surgical
• Interventions: Device: endoscopic suturing

• Registration Number: NCT01139424
• Lead Sponsor: University Hospital Schleswig-Holstein

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-05
• Study First Submitted: 2010-05-28
• Study Start: 2010-06
• Study First Submitted QC: 2010-06-07
• Last Update Submitted: 2010-06-07
• Study First Posted: 2010-06-08
• Last Update Posted: 2010-06-08
• Primary Completion: 2012-06
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
open label treatment arm	endoscopic suturing	endoscopic suturing

Primary Outcome Measures

Name	Time	Method
Safety	2 years	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
Technical feasibility	2 years	Technical success of the anastomotic closure

Secondary Outcome Measures

Name	Time	Method
Time to healing of the anastomotic leak	2 years	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.
Long term safety	6 months after diagnosis of anastomotic leakage	Long term safety; * Anastomotic stenosis, as assessed by endoscopy; * Clinically apparent functional problems (e.g. dysphagia, incontinence)

Trial Locations

Locations (1)

UKSH; 🇩🇪 Kiel, SH, Germany