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Clinical Trials/NCT00427752
NCT00427752
Completed
Early Phase 1

Diagnostic Transluminal Endoscopic Peritoneoscopy

Jeffrey Hazey1 site in 1 country20 target enrollmentOctober 2006

Overview

Phase
Early Phase 1
Intervention
Not specified
Conditions
Pancreatic Cancer
Sponsor
Jeffrey Hazey
Enrollment
20
Locations
1
Primary Endpoint
1) That transgastric endoscopic peritoneoscopy is feasible.
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2006
End Date
January 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Jeffrey Hazey
Responsible Party
Sponsor Investigator
Principal Investigator

Jeffrey Hazey

Associate Professor

Ohio State University

Eligibility 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

Outcomes

Primary Outcomes

1) That transgastric endoscopic peritoneoscopy is feasible.

Time Frame: 4/12

Secondary Outcomes

  • That bacterial abdominal contamination is not clinically significant.(04/11)

Study Sites (1)

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