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Abdominal Exploration Without Incisions

This study has been completed.
Sponsor:
Collaborators:
Stryker Nordic
Ethicon Endo-Surgery
Information provided by (Responsible Party):
Jeffrey Hazey, The Ohio State University
ClinicalTrials.gov Identifier:
NCT00427752
First received: January 25, 2007
Last updated: May 3, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention Phase
Pancreatic Cancer
 Procedure: Transgastric endoscopic peritoneoscopy.
 Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Diagnostic Transluminal Endoscopic Peritoneoscopy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • 1) That transgastric endoscopic peritoneoscopy is feasible. [ Time Frame: 4/12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • That bacterial abdominal contamination is not clinically significant. [ Time Frame: 04/11 ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: October 2006
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Whipple
Patients with pancreatic cancer who will proceed to a Whipple procedure.
 Procedure: Transgastric endoscopic peritoneoscopy.
Exploration of the abdominal area

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00427752

Locations
United States, Ohio
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
  More Information

Publications:

Responsible Party: Jeffrey Hazey, Associate Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT00427752     History of Changes
Other Study ID Numbers: 2006H0120
Study First Received: January 25, 2007
Last Updated: May 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
Transgastric
Endoluminal
Peritoneoscopy
Diagnostic
Feasibility

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013