Abdominal Exploration Without Incisions
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Whipple Patients with pancreatic cancer who will proceed to a Whipple procedure. |
Procedure: Transgastric endoscopic peritoneoscopy.
Exploration of the abdominal area
|
Outcome Measures
Primary Outcome Measures
- 1) That transgastric endoscopic peritoneoscopy is feasible. [4/12]
Secondary Outcome Measures
- That bacterial abdominal contamination is not clinically significant. [04/11]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Pancreatic Cancer undergoing staging laparoscopy
-
Staging or diagnostic laparoscopy in anyone needing enteral access
Exclusion Criteria:
-
Lack of consent
-
Intra-abdominal adhesions precluding diagnostic laparoscopy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Ohio State University Center for Minimally Invasive Surgery | Columbus | Ohio | United States | 43210 |
Sponsors and Collaborators
- Jeffrey Hazey
- Stryker Nordic
- Ethicon Endo-Surgery
Investigators
- Principal Investigator: Jeffrey W Hazey, MD, Ohio State University
- Principal Investigator: William S Melvin, MD, Ohio State University
Study Documents (Full-Text)
None provided.More Information
Publications
- Cios TJ, Reavis KM, Renton DR, Hazey JW, Mikami DJ, Narula VK, Allemang MT, Davis SS, Melvin WS. Gastrotomy closure using bioabsorbable plugs in a canine model. Surg Endosc. 2008 Apr;22(4):961-6. Epub 2007 Aug 19.
- Hazey JW, Dunkin BJ, Melvin WS. Changing attitudes toward endolumenal therapy. Surg Endosc. 2007 Mar;21(3):445-8.
- Malik A, Mellinger JD, Hazey JW, Dunkin BJ, MacFadyen BV Jr. Endoluminal and transluminal surgery: current status and future possibilities. Surg Endosc. 2006 Aug;20(8):1179-92. Epub 2006 Jul 24. Review.
- Narula VK, Hazey JW, Renton DB, Reavis KM, Paul CM, Hinshaw KE, Needleman BJ, Mikami DJ, Ellison EC, Melvin WS. Transgastric instrumentation and bacterial contamination of the peritoneal cavity. Surg Endosc. 2008 Mar;22(3):605-11. Epub 2007 Nov 20.
- 2006H0120