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

• Sponsor: University Hospital Schleswig-Holstein (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01139424
• Collaborator: Ethicon Endo-Surgery (Industry)
• Enrollment: 60
• Location: 1
• Arm: 1
• Duration (Months): 24
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative; Anastomosis, Surgical	Device: endoscopic suturing	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety and Efficacy of Closure of Postoperative Anastomotic Leaks in the Stomach and Esophagus by Endoscopic Suturing: A Prospective Pilot Study
• Study Start Date: Jun 1, 2010
• Anticipated Primary Completion Date: Jun 1, 2012
• Anticipated Study Completion Date: Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: open label treatment arm endoscopic suturing	Device: endoscopic suturing; endoscopic suturing of the anastomotic leak; Other Names: Using the Ethicon Endosurgery InScope tissue apposition system (TAS). FDA regulation number 21 CFR 876.1500, CE#: CE0123 (G2S 09 12 57666 029)

Outcome Measures

Primary Outcome Measures

1. 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

2. Technical feasibility [2 years]

   Technical success of the anastomotic closure

Secondary Outcome Measures

1. 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.

2. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UKSH	Kiel	SH	Germany	24105

Sponsors and Collaborators

• University Hospital Schleswig-Holstein
• Ethicon Endo-Surgery

Investigators

• Principal Investigator: Annette Fritscher-Ravens, MD, UKSH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01139424
• Other Study ID Numbers: 1-Fritscher-Ravens; UKSH1
• First Posted: Jun 8, 2010
• Last Update Posted: Jun 8, 2010
• Last Verified: May 1, 2010

• Keywords provided by , ,: surgical leak; endoscopic suturing; Anastomotic leakage; esophageal or gastric resection
• Additional relevant MeSH terms: Anastomotic Leak

Study Results

No Results Posted as of Jun 8, 2010