Endoscopic Treatment of Intestinal Fistulas and Perforations

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Ethicon Endo-Surgery
Information provided by:
Legacy Health System
ClinicalTrials.gov Identifier:
NCT00835458
First received: February 2, 2009
Last updated: February 10, 2009
Last verified: February 2009
  Purpose

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 Intervention
Gastric Fistula
Procedure: gastro-gastric fistula closure

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Closure of Fistulas and Perforations Endoscopically to Avoid Laparoscopic or Open Surgery

Resource links provided by NLM:


Further study details as provided by Legacy Health System:

Primary Outcome Measures:
  • fistula or perforation closure possible; yes or no [ Time Frame: day of surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • fistula stays closed after 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • quality of life comparison, pre-op and after 6 months post-op [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: February 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00835458

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

Additional Information:
Publications:
Responsible Party: Lee Swanstrom, Legacy Health System
ClinicalTrials.gov Identifier: NCT00835458     History of Changes
Other Study ID Numbers: IIS GRANT#25206
Study First Received: February 2, 2009
Last Updated: February 10, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Legacy Health System:
gastric fistula
perforation
endoscopy
closure
endolumenal

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

ClinicalTrials.gov processed this record on October 23, 2014