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Abdominal Exploration Without Incisions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00427752
First Posted: January 29, 2007
Last Update Posted: May 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Stryker Nordic
Ethicon Endo-Surgery
Information provided by (Responsible Party):
Jeffrey Hazey, The Ohio State University
  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. Early Phase 1

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

Resource links provided by NLM:


Further study details as provided by Jeffrey Hazey, The Ohio State University:

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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: January 25, 2007
First Posted: January 29, 2007
Last Update Posted: May 7, 2012
Last Verified: May 2012

Keywords provided by Jeffrey Hazey, The 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