Clinical Trials Logo

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


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
See also
  Status Clinical Trial Phase
Recruiting NCT00471029 - Compare Efficacy of Gastric Acid Suppression by Oral and Intravenous Administration of Esomeprazole in Patients With Peptic Ulcer Phase 4
Completed NCT00152399 - Study to Assess the Efficacy and Safety of Somatostatin in the Treatment of Acute Severe Upper Gastrointestinal Bleeding Phase 2
Not yet recruiting NCT02961296 - Helicobacter Pylori Antibiotic Susceptibility Testing of Korea N/A
Completed NCT00212225 - Risk Factors for Gastric Disease in Pediatric Helicobacter Pylori (H. Pylori) N/A
Completed NCT02342470 - Efficacy and Safety of PMK-S005 in the Prevention of Recurrent Peptic Ulcer in Low-dose Aspirin Users Phase 2
Completed NCT02296021 - Helicobacter Pylori Eradication With Berberine Quadruple Therapy Versus Bismuth-containing Quadruple Therapy Phase 4
Completed NCT00977678 - Drop in Gastroscopy - Experience After 9 Months N/A
Terminated NCT04025983 - Effectiveness of GastimunHp Plus in Supporting the Treatment of Peptic Ulcer Disease With Helicobacter Pylori Infection N/A
Recruiting NCT03868267 - Japanese Upper GI Symptoms Compared With Iranian and Canadian Patients Presenting
Completed NCT05237115 - Helicobacter Pylori Eradication With Probiotics Combined With Triple Therapy Versus Bismuth-containing Quadruple Therapy Phase 4
Completed NCT01667718 - Bismuth Improves the Efficacy of Levofloxacin-containing Triple Therapy for Helicobacter Pylori Treatment Phase 4
Not yet recruiting NCT04784910 - Study to Evaluate the Efficacy and Safety of DWP14012 in Prevention of NSAIDs Induced Peptic Ulcer Phase 3
Recruiting NCT02436018 - WEI NASAL JET for The Sedation of Outpatient Upper Gastrointestinal Endoscopy N/A
Completed NCT03367897 - Bleeding Ulcer and Erosions Study "BLUE Study"
Active, not recruiting NCT02001727 - HEP-FYN 12-Years Follow-up N/A
Completed NCT01376414 - H. Pylori Testing for Patients With Non-specific Upper Abdominal Pain in the Emergency Department N/A
Completed NCT01667692 - Aizthromycin or Clarithromycin in H-pylori Eradication Regimen Phase 4
Completed NCT02536989 - Different Dose of Intravenous Omeprazole to Treat Bleeding Ulcer With Adherent Clot Phase 4
Completed NCT00920400 - Diagnostic Value of Fecal Calprotectin in Disorders of the Upper Gastrointestinal Tract N/A
Completed NCT00450658 - Efficacy and Safety Study of HZT-501 in Reducing the Risk of Ibuprofen-associated Ulcers Phase 3