Clinical trial NCT00835458: Endoscopic Treatment of Intestinal Fistulas and Perforations
Official title: Closure of Fistulas and Perforations Endoscopically to Avoid Laparoscopic or Open Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Fistula
Keywords: gastric fistula
perforation
endoscopy
closure
endolumenal
Lead sponsor: Legacy Health System
Sponsor class: OTHER
Collaborators: name: Ethicon Endo-Surgery
First posted: 2009-02-03
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: fistula or perforation closure possible; yes or no
timeFrame: day of surgery
Secondary outcomes:
measure: fistula stays closed after 6 months
timeFrame: 6 months
measure: quality of life comparison, pre-op and after 6 months post-op
timeFrame: 6 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Good Samaritan Hospital, Legacy Health System
state: Oregon
Study officials:
affiliation: Legacy Health System
name: Lee L Swanstrom, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/j.gie.2006.01.050.
citation: Raju GS, Fritscher-Ravens A, Rothstein RI, Swain P, Gelrud A, Ahmed I, Gomez G, Winny M, Sonnanstine T, Bergstrom 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.
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.
citation: Bergstrom 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.