Endoscopic Treatment of Intestinal Fistulas and Perforations

Gastrointestinal Fistula Clinical Trial

Official title:

Endoscopic Treatment of Intestinal Fistulas and Perforations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01303653
• Other study ID #: LEG 1280
• Status: Recruiting
• Phase: Phase 1
• First received: February 24, 2011
• Last updated: February 25, 2011
• Start date: October 2010

Study information

• Verified date: July 2010
• Source: The Oregon Clinic
• Contact: Lee L Swanstrom, MD
• Phone: 503 281 0561
• Email: lswanstrom[@]aol.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Gastrointestinal leaks or perforations are currently treated through either open or laparoscopic surgical procedures. The purpose of this research is to determine whether new endoscopic tools are safe and effective in the treatment of such conditions and can overcome the need of invasive surgical procedures.

Description:

Novel endoscopic devices have the potential to overcome the need for invasive surgery for the treatment of gastrointestinal fistulas or perforations.

Instead of a large abdominal incision or multiple incisions with the related postoperative morbidity endoscopic techniques will be used used which require no postoperative limitation of activities. Using novel tissue closure devices, such as a Tissue Apposition System or an endoscopic suturing system, we will evaluate the potential benefit, risks and impact on the patient's quality of life of this modified surgical technique in patients having either chronic gastrointestinal fistulas or acute perforations.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Gastrointestinal fistula and perforation

• Ability to undergo general anesthesia

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Digestive System Fistula
• Fistula
• Gastrointestinal Fistula
• Gastrointestinal Perforation
• Intestinal Fistula

Intervention

Procedure:
• endoscopic closure of gastrointestinal fistulas and perforations
novel endoscopic tissue closure devices will be used for endoscopic closure of gastrointestinal fistulas or perforations

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
The Oregon Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events as a measure of safety and tolerability	elective endoscopy to evaluate tissue closure	6 months	Yes