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

Study Status: Enrolling by invitation
Recruit Status: Unknown status
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: University of Schleswig-Holstein

Current Primary Outcome:

  • 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
  • Technical feasibility [ Time Frame: 2 years ]
    Technical success of the anastomotic closure


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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)


Original Secondary Outcome: Same as current

Information By: University of Schleswig-Holstein

Dates:
Date Received: May 28, 2010
Date Started: June 2010
Date Completion: June 2012
Last Updated: June 7, 2010
Last Verified: May 2010