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Feasibility of Translumenal Endoscopic Omental Patch Closure of Perforated Viscus

This study has been completed.
Sponsor:
Collaborator:
Natural Orifice Surgery Consortium for Assessment and Research
Information provided by (Responsible Party):
Juliane Bingener-Casey, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01080326
First received: March 2, 2010
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

This study is being done to see if a new approach to repair perforated ulcers in the stomach (holes in the stomach) or the first part of the intestine will work as well or better than the current methods. Traditionally, either open operations (large single incision) or laparoscopic operations (multiple small camera-guided incisions) have been used to repair perforated ulcers. Over the last ten years, some surgeons have used endoscopic equipment to assist them with performing the procedure. It is unknown if perforated ulcer repair can be done using an endoscope as the main instrument (a flexible tube with a video camera inserted into the stomach through your esophagus) to "patch" or plug the perforation. We will patch the perforation using a standard method which uses tissue from outside the stomach. A laparoscopic camera will also be used to assist our view. An endoscope may be safer than open or laparoscopic surgery and lead to less complications but we will not know this until we do the study. This endoscope is approved by the US Food and Drug Administration (FDA) and has been used for many years to look inside the stomach; however, we will also use it in the study procedure to deliver our instruments into and through the hole in the subject's stomach or the first part of the subject's intestine.

Hypothesis: Endoscopic translumenal omental patch closure will be successful in > 80% of patients with perforated peptic ulcer as evidenced by intra-operative leak test and postoperative gastrografin swallow.


Condition Intervention
Peptic Ulcer
 Device: Endoscopic Translumenal Omental Patch

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility of Translumenal Endoscopic Omental Patch Closure of Perforated Viscus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Successful completion of the procedure. At the time of surgery the repair will be pressure tested using endoscopic insufflation. Post-op all patients will undergo Gastrografin swallow to evaluate for leak. [ Time Frame: Leak Evaluation during surgery and 2 days post-op ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary outcome data such as pain score and quality of life, heart rate variability analysis will be collected to establish pilot data for possible future trials if feasibility is established. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 3
Study Start Date: March 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endoscopic Translumenal Omental Patch
Patients with the clinical diagnosis of a perforated viscus who are scheduled to undergo surgical exploration will be recruited. The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix the Endoscopic Translumenal Omental Patch in place.
 Device: Endoscopic Translumenal Omental Patch
The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix it in place.
Other Name: Ulcer repair surgery

Detailed Description:

Perforation is the most dangerous complication of gastroduodenal ulcer disease. It accounts for more than 70% of deaths associated with peptic ulcer disease. In addition to age and concomitant disease, intervention related complications are statistically significant predictors of death after hospital stay. Age, time to presentation and comorbidities are not factors that can be influenced. If it would be possible to reduce the impact of procedure related complications or the "second hit", that may lead to decreased morbidity and mortality.

We propose to prospectively study the feasibility of an endoscopic transluminal omental patch closure in patients with perforated viscus. Endoscopy has been used as an adjunct for laparoscopic omentoplasty in perforated ulcers in the past and endoscopic omental patch closure of iatrogenic perforations has been reported. An endoscopic approach would also allow H.pylori or cancer diagnosis and for gastric outlet/duodenal lumen observation before and after patch placement. In addition, over time it may be possible to perform this procedure without general anesthesia; thus, leading to decreased invasiveness and possibly decrease mortality. The feasibility of this endoscopic approach should be studied under laparoscopic guidance and under circumstances in which a traditional open or laparoscopic approach could be easily instituted.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients presenting with clinical diagnosis of a perforated viscus who are scheduled to undergo surgical intervention
  • Surgical candidate for endoscopic, laparoscopic, or open procedure
  • Age > 18
  • Informed written consent

Exclusion Criteria:

  • Prior gastric or duodenal surgery
  • Prior total abdominal colectomy or transverse colectomy
  • Prior omentectomy or omental flaps
  • Known perforation site other than stomach or duodenum
  • Patients with contra-indications for laparoscopy
  • Patients with contraindications for endoscopy
  • Upper gastrointestinal anatomy that would preclude endoscopic therapy
  • Coagulopathy or thrombocytopenia
  • Pregnant patients
  • Patients <18 years of age
  • Prisoners
  • Patients found at surgery to have disease processes other than perforated peptic ulcer disease will be asked for permission to record their data for comparison
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01080326

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Natural Orifice Surgery Consortium for Assessment and Research
Investigators
Principal Investigator: Juliane Bingener-Casey, MD.S Mayo Clinic
  More Information

No publications provided

Responsible Party: Juliane Bingener-Casey, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01080326     History of Changes
Other Study ID Numbers: 08-008389
Study First Received: March 2, 2010
Last Updated: January 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
ulcer repair surgery
transluminal omental patch

Additional relevant MeSH terms:
Peptic Ulcer
Ulcer
Duodenal Diseases
Intestinal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013