Feasibility of Translumenal Endoscopic Omental Patch Closure of Perforated Viscus

Peptic Ulcer Clinical Trial

Official title:

Feasibility of Translumenal Endoscopic Omental Patch Closure of Perforated Viscus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01080326
• Other study ID #: 08-008389
• Secondary ID: ULIRR024150
• Status: Completed
• Phase: N/A
• First received: March 2, 2010
• Last updated: April 1, 2015
• Start date: March 2010
• Est. completion date: December 2012

Study information

• Verified date: April 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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 is possible. 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. This study is intended to be a feasibility study to demonstrate the endoscopic technique can be safely performed

Hypothesis: The primary outcome is successful completion of the procedure.

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.

This will be a pilot clinical study to evaluate the safety and feasibility of endoscopic translumenal omental patch closure. Patients with the clinical diagnosis of a perforated viscus who are scheduled to undergo surgical exploration will be recruited. Endoscopic translumenal omental patch will be attempted first if the patient has no contraindication. Should this prove unsuccessful, the surgical team will proceed with conversion to laparoscopic or open standard surgical therapy as indicated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 > 21

• 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 <21 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Peptic Ulcer

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Natural Orifice Surgery Consortium for Assessment and Research

Country where clinical trial is conducted

United States, 

References & Publications (1)

Bingener J, Loomis EA, Gostout CJ, Zielinski MD, Buttar NS, Song LM, Baron TH, Ghahfarokhi LS, Rajan E. Feasibility of NOTES omental plug repair of perforated peptic ulcers: results from a clinical pilot trial. Surg Endosc. 2013 Jun;27(6):2201-8. doi: 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Completing Natural Orifice Translumenal Endoscopic Surgical (NOTES) Repair	At the time of surgery the repair was pressure tested using endoscopic insufflation. Two days post-operation all participants receiving the NOTES repair underwent a water-soluble contrast study to demonstrate leakage.; Note: The NOTES procedure was attempted first if the subject had no contraindication. If this proved unsuccessful the surgical team proceeded with conversion to laparoscopic or open standard surgical therapy as indicated.	2 days post-operation	Yes