Endoscopic Treatment of Intestinal Fistulas and Perforations

The Oregon Clinic

Status and phase: Unknown; Phase 1

Conditions: Gastrointestinal Perforation; Gastrointestinal Fistula

Treatments: Procedure: endoscopic closure of gastrointestinal fistulas and perforations

Study type: Interventional

Funder types: Other

Identifiers

NCT01303653

LEG 1280

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)