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Diagnostic Endoscopic Exploration for Pancreatic Head Mass

This study is currently recruiting participants.
Verified February 2013 by Ohio State University
Sponsor:
Collaborator:
Natural Orifice Surgery Consortium for Assessment and Research
Information provided by (Responsible Party):
Jeffrey Hazey, The Ohio State University
ClinicalTrials.gov Identifier:
NCT00816179
First received: December 30, 2008
Last updated: February 7, 2013
Last verified: February 2013
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Cancer Endoscopy
U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 40
Study Start Date: July 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00816179

Contacts
Contact: Rebecca R Dettorre, BA 614-293-8549 becky.dettorre@osumc.edu
Contact: Peter Nau, MD 614-293-9964 peter.nau@osumc.edu

Locations
United States, Ohio
The Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Rebecca R Dettorre, BA     614-293-8549     becky.dettorre@osumc.edu    
Contact: Peter Nau, MD     614-293-9964     peter.nau@osumc.edu    
Principal Investigator: Jeffrey W Hazey, MD            
Sub-Investigator: Mark Bloomston, MD            
Sub-Investigator: W Scott Melvin, MD            
Sub-Investigator: E Christophe Ellison, MD            
Sub-Investigator: Peter Muscarella, MD            
Sub-Investigator: Vimal K Narula, MD            
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:
Home page for OSUMC Center for Minimally Invasive Surgery  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Jeffrey Hazey, Associate Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT00816179     History of Changes
Other Study ID Numbers: 2007C0086
Study First Received: December 30, 2008
Last Updated: February 7, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Marfan Syndrome
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
 Cardiovascular Diseases
Heart Diseases
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Connective Tissue Diseases

ClinicalTrials.gov processed this record on June 17, 2013