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

June 7, 2010 updated by: University Hospital Schleswig-Holstein

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Annette Fritscher-Ravens, MD
  • Phone Number: 0049-431-597-2133

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 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 years
Technical feasibility
Time Frame: 2 years
Technical success of the anastomotic closure
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to healing of the anastomotic leak
Time Frame: 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 years
Long term safety
Time Frame: 6 months after diagnosis of anastomotic leakage

Long term safety

  • Anastomotic stenosis, as assessed by endoscopy
  • Clinically apparent functional problems (e.g. dysphagia, incontinence)
6 months after diagnosis of anastomotic leakage

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Schleswig-Holstein

Collaborators

Ethicon Endo-Surgery

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ANTICIPATED)

June 1, 2012

Study Completion (ANTICIPATED)

June 1, 2012

Study Registration Dates

First Submitted

May 28, 2010

First Submitted That Met QC Criteria

June 7, 2010

First Posted (ESTIMATE)

June 8, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 8, 2010

Last Update Submitted That Met QC Criteria

June 7, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-Fritscher-Ravens
  • UKSH1 (OTHER: UKSH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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