Endoscopic Treatment of Intestinal Fistulas and Perforations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastric Fistula

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Tissue Apposition System TAS 510(k) approval # K070151

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No