Endoscopic Treatment of Intestinal Fistulas and Perforations

Gastric Fistula Clinical Trial

Official title:

Closure of Fistulas and Perforations Endoscopically to Avoid Laparoscopic or Open Surgery

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00835458
• Other study ID #: IIS GRANT#25206
• Status: Unknown status
• Phase: N/A
• First received: February 2, 2009
• Last updated: February 10, 2009
• Start date: February 2009
• Est. completion date: December 2010

Study information

• Verified date: February 2009
• Source: Legacy Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 5
• Est. completion date: December 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Fistula
• Gastric Fistula

Intervention

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.

Locations

Country	Name	City	State
United States	Good Samaritan Hospital, Legacy Health System	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Legacy Health System	Ethicon Endo-Surgery

Country where clinical trial is conducted

United States, 

References & Publications (4)

Bergström M, Swain P, Park PO. Early clinical experience with a new flexible endoscopic suturing method for natural orifice transluminal endoscopic surgery and intraluminal endosurgery (with videos). Gastrointest Endosc. 2008 Mar;67(3):528-33. doi: 10.1016/j.gie.2007.09.049. — View Citation

Raju GS, Fritscher-Ravens A, Rothstein RI, Swain P, Gelrud A, Ahmed I, Gomez G, Winny M, Sonnanstine T, Bergström M, Park PO. Endoscopic closure of colon perforation compared to surgery in a porcine model: a randomized controlled trial (with videos). Gastrointest Endosc. 2008 Aug;68(2):324-32. doi: 10.1016/j.gie.2008.03.006. Epub 2008 Jun 17. Erratum in: Gastrointest Endosc. 2008 Sep;68(3):616. — View Citation

Sporn E, Miedema BW, Bachman SL, Astudillo JA, Loy TS, Calaluce R, Thaler K. Endoscopic colotomy closure after full thickness excision: comparison of T fastener with multiclip applier. Endoscopy. 2008 Jul;40(7):589-94. doi: 10.1055/s-2008-1077377. — View Citation

Sumiyama K, Gostout CJ, Rajan E, Bakken TA, Deters JL, Knipschield MA. Endoscopic full-thickness closure of large gastric perforations by use of tissue anchors. Gastrointest Endosc. 2007 Jan;65(1):134-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fistula or perforation closure possible; yes or no		day of surgery
Secondary	fistula stays closed after 6 months		6 months
Secondary	quality of life comparison, pre-op and after 6 months post-op		6 months

External Links

•   Evaluation of an Endoscopic Suturing System for Tissue Apposition in Colonic Polypectomy