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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01139424
Recruitment Status : Unknown
Verified May 2010 by University of Schleswig-Holstein.
Recruitment status was:  Not yet recruiting
First Posted : June 8, 2010
Last Update Posted : June 8, 2010
Ethicon Endo-Surgery
Information provided by:
University of 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.

Condition or disease Intervention/treatment Phase
Postoperative Anastomosis, Surgical Device: endoscopic suturing Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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 : June 2010
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

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)

Primary Outcome Measures :
  1. 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. Technical feasibility [ Time Frame: 2 years ]
    Technical success of the anastomotic closure

Secondary Outcome Measures :
  1. 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. 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01139424

Contact: Annette Fritscher-Ravens, MD 0049-431-597-2133

UKSH Not yet recruiting
Kiel, SH, Germany, 24105
Contact: Annette Fritscher-Ravens, MD    0049-431-597-2133   
Contact: Gudrun Gebhard    0049-431-597-1464   
Principal Investigator: Annette Fritscher-Ravens, MD         
Sponsors and Collaborators
University of Schleswig-Holstein
Ethicon Endo-Surgery
Principal Investigator: Annette Fritscher-Ravens, MD UKSH

Responsible Party: Professor Fritscher-Ravens, UKSH Identifier: NCT01139424     History of Changes
Other Study ID Numbers: 1-Fritscher-Ravens
UKSH1 ( Other Identifier: UKSH )
First Posted: June 8, 2010    Key Record Dates
Last Update Posted: June 8, 2010
Last Verified: May 2010

Keywords provided by University of Schleswig-Holstein:
surgical leak
endoscopic suturing
Anastomotic leakage
esophageal or gastric resection

Additional relevant MeSH terms:
Anastomotic Leak
Postoperative Complications
Pathologic Processes