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2006-10
2012-01
2012-01
20
NCT00427752
Ohio State University
Ohio State University
INTERVENTIONAL
Abdominal Exploration Without Incisions
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2007-01-25 | N/A | 2012-05-03 |
2007-01-26 | N/A | 2012-05-07 |
2007-01-29 | N/A | 2012-05 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Na
Interventional Model:
Single Group
Masking:
Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Whipple Patients with pancreatic cancer who will proceed to a Whipple procedure. | PROCEDURE: Transgastric endoscopic peritoneoscopy.
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 1) That transgastric endoscopic peritoneoscopy is feasible. | 4/12 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| That bacterial abdominal contamination is not clinically significant. | 04/11 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
