- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00427752
Abdominal Exploration Without Incisions
Diagnostic Transluminal Endoscopic Peritoneoscopy
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- The Ohio State University Center for Minimally Invasive Surgery
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Whipple
Patients with pancreatic cancer who will proceed to a Whipple procedure.
|
Exploration of the abdominal area
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
1) That transgastric endoscopic peritoneoscopy is feasible.
Time Frame: 4/12
|
4/12
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
That bacterial abdominal contamination is not clinically significant.
Time Frame: 04/11
|
04/11
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: William S Melvin, MD, Ohio State University
Publications and helpful links
General Publications
- 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. doi: 10.1007/s00464-007-9661-6. Epub 2007 Nov 20.
- 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. doi: 10.1007/s00464-007-9530-3. Epub 2007 Aug 19.
- Hazey JW, Dunkin BJ, Melvin WS. Changing attitudes toward endolumenal therapy. Surg Endosc. 2007 Mar;21(3):445-8. doi: 10.1007/s00464-006-9001-2.
- 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. doi: 10.1007/s00464-005-0711-7. Epub 2006 Jul 24.
- Hazey JW, Narula VK, Renton DB, Reavis KM, Paul CM, Hinshaw KE, Muscarella P, Ellison EC, Melvin WS. Natural-orifice transgastric endoscopic peritoneoscopy in humans: Initial clinical trial. Surg Endosc. 2008 Jan;22(1):16-20. doi: 10.1007/s00464-007-9548-6. Epub 2007 Aug 14.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2006H0120
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Transgastric endoscopic peritoneoscopy.
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University of Missouri-ColumbiaWithdrawn
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Jeffrey HazeyNatural Orifice Surgery Consortium for Assessment and Research; Stryker SACompleted
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John Gasdal KarstensenCompleted
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Heidelberg UniversityCompleted