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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by University of Schleswig-Holstein.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Ethicon Endo-Surgery
Information provided by:
University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT01139424
First received: May 28, 2010
Last updated: June 7, 2010
Last verified: May 2010
  Purpose

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 Intervention
Postoperative
Anastomosis, Surgical
Device: endoscopic suturing

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Schleswig-Holstein:

Primary Outcome Measures:
  • Safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Technical success of the anastomotic closure


Secondary Outcome Measures:
  • Time to healing of the anastomotic leak [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months after diagnosis of anastomotic leakage ] [ Designated as safety issue: Yes ]

    Long term safety

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


Estimated Enrollment: 60
Study Start Date: June 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01139424

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

Locations
Germany
UKSH Not yet recruiting
Kiel, SH, Germany, 24105
Contact: Annette Fritscher-Ravens, MD    0049-431-597-2133    fritscher-ravens@1med.uni-kiel.de   
Contact: Gudrun Gebhard    0049-431-597-1464    Gudrun.Gebhardt@uk-sh.de   
Principal Investigator: Annette Fritscher-Ravens, MD         
Sponsors and Collaborators
University of Schleswig-Holstein
Ethicon Endo-Surgery
Investigators
Principal Investigator: Annette Fritscher-Ravens, MD UKSH
  More Information

No publications provided

Responsible Party: Professor Fritscher-Ravens, UKSH
ClinicalTrials.gov Identifier: NCT01139424     History of Changes
Other Study ID Numbers: 1-Fritscher-Ravens, UKSH1
Study First Received: May 28, 2010
Last Updated: June 7, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on September 16, 2014