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

February 2, 2009
February 10, 2009
February 2009
October 2009   (final data collection date for primary outcome measure)
fistula or perforation closure possible; yes or no [ Time Frame: day of surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00835458 on ClinicalTrials.gov Archive Site
  • 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 ]
  • fistula stays closed after 6 month [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • quality of life comparison, pre-op and after 6 month post-op [ Time Frame: 6 month ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Endoscopic Treatment of Intestinal Fistulas and Perforations
Closure of Fistulas and Perforations Endoscopically to Avoid Laparoscopic or Open Surgery

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastric Fistula
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
5
December 2010
October 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00835458
IIS GRANT#25206
No
Lee Swanstrom, Legacy Health System
Legacy Health System
Ethicon Endo-Surgery
Principal Investigator: Lee L Swanstrom, MD, FACS Legacy Health System
Legacy Health System
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP