Endoscopic Treatment of Intestinal Fistulas and Perforations

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by The Oregon Clinic.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The Oregon Clinic
ClinicalTrials.gov Identifier:
NCT01303653
First received: February 24, 2011
Last updated: February 25, 2011
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Gastrointestinal Fistula
Gastrointestinal Perforation
Procedure: endoscopic closure of gastrointestinal fistulas and perforations
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endoscopic Treatment of Intestinal Fistulas and Perforations

Resource links provided by NLM:


Further study details as provided by The Oregon Clinic:

Primary Outcome Measures:
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    elective endoscopy to evaluate tissue closure


Estimated Enrollment: 25
Study Start Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: endoscopic closure of gastrointestinal fistulas and perforations
    novel endoscopic tissue closure devices will be used for endoscopic closure of gastrointestinal fistulas or perforations
    Other Names:
    • Either the Tissue Apposition System (Ethicon Endosurgery)
    • or the Overstitch (Apollo Endosurgery)
    • will be used within this study for tissue closure
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01303653

Contacts
Contact: Lee L Swanstrom, MD 503 281 0561 lswanstrom@aol.com

Locations
United States, Oregon
Good Samaritan Hospital, Legacy Health System Recruiting
Portland, Oregon, United States, 97210
Contact: Lee L Swanstrom, MD    503-281-0561    lswanstrom@aol.com   
Sub-Investigator: Erwin Rieder, MD         
Sub-Investigator: Angi Gill, RN         
Sponsors and Collaborators
The Oregon Clinic
  More Information

No publications provided

Responsible Party: Lee L. Swanstrom, MD, The Oregon Clinic
ClinicalTrials.gov Identifier: NCT01303653     History of Changes
Other Study ID Numbers: LEG 1280
Study First Received: February 24, 2011
Last Updated: February 25, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by The Oregon Clinic:
endoscopic tissue closure,
gastro-gastric fistulas,
gastrointestinal perforations

Additional relevant MeSH terms:
Fistula
Intestinal Fistula
Pathological Conditions, Anatomical
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on September 18, 2014