Endoscopic Treatment of Intestinal Fistulas and Perforations

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: NCT00835458
Recruitment Status : Unknown
Verified February 2009 by Legacy Health System.
Recruitment status was:  Enrolling by invitation
First Posted : February 3, 2009
Last Update Posted : February 11, 2009
Ethicon Endo-Surgery
Information provided by:
Legacy Health System

Brief Summary:

Background: T-shaped tissue anchors have promise to close incisions and perforations of the intestines securely. The closure of perforations, gastro-gastric, or intestinal fistulas usually requires invasive open or laparoscopic surgery under general anesthesia and can be complex surgeries due to their reoperative or inflammatory nature.

Objective: The proposed use of full thickness tissue anchors adds a new surgical aspect to the endoscopic treatment of fistulas and perforations by offering a robust suture like closure of defects. Instead of a 20 cm abdominal incision or 3 or 4 one centimeter incisions with the related postoperative morbidity an endoscopic technique is used which requires no postoperative limitation of activities.

Methods: In this study the investigators propose to use an endoscopic technique that eliminates the need for open or laparoscopic surgery and provides a more robust endoscopic repair than is possible with traditional endoscopic tools. Patients who are scheduled to undergo surgery for intestinal fistulas will be screened for study eligibility. Patients who are scheduled to undergo complex polypectomy, or submucosal dissection will be screened for study eligibility and informed about all possible therapies in case of an iatrogenic perforation (open - laparoscopic surgery, endoscopic clipping, endoscopic closure with tissue anchors). A commercially available flexible endoscope will be inserted through the mouth and the fistula or perforation will be closed using the Tissue Approximation System (Ethicon Endo Surgery, Cincinnati, OH).

The investigators will initially evaluate the potential benefit, risks and impact on the patient's quality of life of this modified surgical technique in 5 patients.

Expected results: The potential advantages to the patients entered into this study result from the avoidance of open or laparoscopic surgery with the related risks (bleeding, injury of organs, post operative wound infection, hernia), shorter hospital stay, reduced postoperative pain, earlier return to work, and cosmetic advantage.

Condition or disease Intervention/treatment Phase
Gastric Fistula Procedure: gastro-gastric fistula closure Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Closure of Fistulas and Perforations Endoscopically to Avoid Laparoscopic or Open Surgery
Study Start Date : February 2009
Estimated Primary Completion Date : October 2009
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas
U.S. FDA Resources

Intervention Details:
    Procedure: gastro-gastric fistula closure
    The mucosa surrounding the orifice of the fistula will be ablated using standard endoscopic techniques. Remnants of mucosa will be treated with argon-plasma coagulation. The mucosa free orifice of the fistula will be closed using the Tissue Apposition System. Tissue anchors with attached threads will be deployed through the intestinal wall full thickness using delivery needles through the working channel of the endoscope. After two anchors are deployed on both sides of the fistulas' orifice a knotting element will be cinched down to approximate the two sides of the fistulas' orifice. The procedure will be repeated until the fistulas' orifice is securely closed.
    Other Names:
    • Tissue Apposition System
    • TAS
    • 510(k) approval # K070151

Primary Outcome Measures :
  1. fistula or perforation closure possible; yes or no [ Time Frame: day of surgery ]

Secondary Outcome Measures :
  1. fistula stays closed after 6 months [ Time Frame: 6 months ]
  2. quality of life comparison, pre-op and after 6 months post-op [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ability to undergo general anesthesia
  • Age > 18 yrs. of age and < 85 yrs. of age
  • Ability to give informed consent

Exclusion Criteria:

  • Contraindicated for esophagogastroduodenoscopy (EGD)
  • Contraindicated for colonoscopy
  • BMI < 40
  • Presence of esophageal stricture
  • Altered gastric anatomy
  • Intraabdominal abscess or severe inflammation
  • Pregnancy

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): NCT00835458

United States, Oregon
Good Samaritan Hospital, Legacy Health System
Portland, Oregon, United States, 97210
Sponsors and Collaborators
Legacy Health System
Ethicon Endo-Surgery
Principal Investigator: Lee L Swanstrom, MD, FACS Legacy Health System

Additional Information:
Responsible Party: Lee Swanstrom, Legacy Health System Identifier: NCT00835458     History of Changes
Other Study ID Numbers: IIS GRANT#25206
First Posted: February 3, 2009    Key Record Dates
Last Update Posted: February 11, 2009
Last Verified: February 2009

Keywords provided by Legacy Health System:
gastric fistula

Additional relevant MeSH terms:
Gastric Fistula
Pathological Conditions, Anatomical
Digestive System Fistula
Digestive System Diseases