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Diagnostic Endoscopic Exploration for Pancreatic Head Mass

This study has been terminated.
(Helical CT scans at our institution preclude the necessity for diagnostic laparoscopy in most cases at our institution.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00816179
First Posted: December 31, 2008
Last Update Posted: November 3, 2014
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.
Collaborator:
Natural Orifice Surgery Consortium for Assessment and Research
Information provided by (Responsible Party):
Jeffrey Hazey, The Ohio State University
  Purpose
This study is being done to find out if an endoscope passed down the throat, through the stomach, and into the abdomen can quickly and accurately examine the organs and tissue of the abdomen and take biopsies if needed.

Condition Intervention
Pancreatic Head Mass Procedure: Transgastric diagnostic endoscopic peritoneoscopy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Human Clinical Trial of Diagnostic Transgastric Endoscopic Peritoneoscopy for Staging of Pancreatic Head Mass

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Endoscopically visualize the abdominal cavity to determine absence or presence of metastatic lesions to successfully stage pancreatic head malignancies and direct surgical treatment. [ Time Frame: Intraoperatively ]

Secondary Outcome Measures:
  • Comparison of laparoscopic exploration (retrospectively) to endoscopic exploration. [ Time Frame: 1 year ]
  • Ability to obtain peritoneal biopsies when appropriate during transgastric endoscopic procedures. [ Time Frame: Intraoperatively ]

Enrollment: 11
Study Start Date: July 2008
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Transgastric diagnostic endoscopic peritoneoscopy
    Endoscopic abdominal exploration utilizing an endoscopically created gastrotomy.
Detailed Description:
This study is being done to find out if an endoscope (a small, flexible tube with a camera mounted on the end) passed down the throat, through the stomach, and into the abdomen can quickly and accurately examine the organs and tissue of the abdomen and take biopsies if needed. We wish to determine if this endoscopic route is as fast and efficient as the laparoscopic route, which is the current standard of care.
  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:

  • Age range 18-80
  • Radiographic diagnosis of resectable pancreatic head mass presumed to be pancreatic adenocarcinoma

Exclusion Criteria:

  • Inability to obtain informed consent
  • Pregnancy
  • Intra-abdominal adhesions that preclude endoscopy
  • Contraindication to upper endoscopy such as stricture, stenosis of the foregut
  • Previous gastric surgery
  • Diagnosis of pancreatic body or tail tumor
  • History or current diagnosis of gastric ulcer
  • Metastatic disease diagnosed by CT, EUS, MRI, or nuclear imaging
  • Patient is not a candidate for resection based upon CT, EUS, MRI, or nuclear imaging
  • Antiplatelet medication not stopped at least 7 days prior to procedure
  • Anticoagulant medication not stopped at least 5 days prior to procedure
  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): NCT00816179


Locations
United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Jeffrey Hazey
Natural Orifice Surgery Consortium for Assessment and Research
Investigators
Principal Investigator: Jeffrey W Hazey, MD OSUMC
  More Information

Additional Information:
Publications:

Responsible Party: Jeffrey Hazey, Associate Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT00816179     History of Changes
Other Study ID Numbers: 2007C0086
First Submitted: December 30, 2008
First Posted: December 31, 2008
Last Update Posted: November 3, 2014
Last Verified: October 2014

Keywords provided by Jeffrey Hazey, The Ohio State University:
Pancreatic head mass
Pancreatic cancer
NOTES
Endoscopic peritoneoscopy
Whipple
palliative gastrojejunostomy