Back to results

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

Primary Purpose

Postoperative, Anastomosis, Surgical

Status

Unknown status

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

endoscopic suturing

About this trial

This is an interventional treatment trial for Postoperative focused on measuring surgical leak, endoscopic suturing, Anastomotic leakage, esophageal or gastric resection

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

UKSH

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

open label treatment arm

Arm Description

endoscopic suturing

Outcomes

Primary Outcome Measures

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

Technical feasibility

Technical success of the anastomotic closure

Secondary Outcome Measures

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.

Long term safety

Long term safety Anastomotic stenosis, as assessed by endoscopy Clinically apparent functional problems (e.g. dysphagia, incontinence)

Full Information

NCT ID

NCT01139424

First Posted

May 28, 2010

Last Updated

June 7, 2010

Sponsor

University Hospital Schleswig-Holstein

Collaborators

Ethicon Endo-Surgery

1. Study Identification

Unique Protocol Identification Number

NCT01139424

Brief Title

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

Acronym

GASTROSUTURE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2010

Overall Recruitment Status

Unknown status

Study Start Date

June 2010 (undefined)

Primary Completion Date

June 2012 (Anticipated)

Study Completion Date

June 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital Schleswig-Holstein

Collaborators

Ethicon Endo-Surgery

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative, Anastomosis, Surgical

Keywords

surgical leak, endoscopic suturing, Anastomotic leakage, esophageal or gastric resection

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

open label treatment arm

Arm Type

Experimental

Arm Description

endoscopic suturing

Intervention Type

Device

Intervention Name(s)

endoscopic suturing

Other Intervention Name(s)

Using the Ethicon Endosurgery InScope tissue apposition system (TAS)., FDA regulation number 21 CFR 876.1500, CE#: CE0123 (G2S 09 12 57666 029)

Intervention Description

endoscopic suturing of the anastomotic leak

Primary Outcome Measure Information:

Title

Safety

Description

Time Frame

2 years

Title

Technical feasibility

Description

Technical success of the anastomotic closure

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Time to healing of the anastomotic leak

Description

Time Frame

2 years

Title

Long term safety

Description

Long term safety Anastomotic stenosis, as assessed by endoscopy Clinically apparent functional problems (e.g. dysphagia, incontinence)

Time Frame

6 months after diagnosis of anastomotic leakage

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Annette Fritscher-Ravens, MD

Phone

0049-431-597-2133

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Annette Fritscher-Ravens, MD

Organizational Affiliation

UKSH

Official's Role

Principal Investigator

Facility Information:

Facility Name

UKSH

City

Kiel

State/Province

ZIP/Postal Code

24105

Country

Germany

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Annette Fritscher-Ravens, MD

Phone

0049-431-597-2133

fritscher-ravens@1med.uni-kiel.de

First Name & Middle Initial & Last Name & Degree

Gudrun Gebhard

Phone

0049-431-597-1464

Gudrun.Gebhardt@uk-sh.de

First Name & Middle Initial & Last Name & Degree

Annette Fritscher-Ravens, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs