Abdominal Exploration Without Incisions
- Conditions
- Pancreatic Cancer
- Interventions
- Procedure: Transgastric endoscopic peritoneoscopy.
- Registration Number
- NCT00427752
- Lead Sponsor
- Jeffrey Hazey
- Brief Summary
This study is being conducted to determine whether an endoscope, (a small, flexible tube with a camera mounted on the end) passed down through the throat, through the stomach, and into the abdomen can safely and accurately examine the organs and tissue of the abdomen and take biopsies if needed. We wish to determine if this endoscopic diagnostic route is as efficient as the laparoscopic diagnostic route, which is currently the standard of care.
- Detailed Description
We propose to investigate the efficacy of transgastric endoscopic peritoneoscopy with endoscopic biopsy in patients undergoing diagnostic laparoscopy and who will require a concurrent gastrotomy for placement of a PEG, gastrojejunostomy or gastric resection.
We hypothesize that diagnostic endoscopic peritoneoscopy can be done safely with adequate visualization of the abdominal cavity to direct clinical treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Pancreatic Cancer undergoing staging laparoscopy
- Staging or diagnostic laparoscopy in anyone needing enteral access
- Lack of consent
- Intra-abdominal adhesions precluding diagnostic laparoscopy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Whipple Transgastric endoscopic peritoneoscopy. Patients with pancreatic cancer who will proceed to a Whipple procedure.
- Primary Outcome Measures
Name Time Method 1) That transgastric endoscopic peritoneoscopy is feasible. 4/12
- Secondary Outcome Measures
Name Time Method That bacterial abdominal contamination is not clinically significant. 04/11
Trial Locations
- Locations (1)
The Ohio State University Center for Minimally Invasive Surgery
🇺🇸Columbus, Ohio, United States