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Diagnostic Endoscopic Exploration for Pancreatic Head Mass

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ClinicalTrials.gov Identifier: NCT00816179
Recruitment Status : Terminated (Helical CT scans at our institution preclude the necessity for diagnostic laparoscopy in most cases at our institution.)
First Posted : December 31, 2008
Last Update Posted : November 3, 2014
Sponsor:
Collaborator:
Natural Orifice Surgery Consortium for Assessment and Research
Information provided by (Responsible Party):
Jeffrey Hazey, Ohio State University

December 30, 2008
December 31, 2008
November 3, 2014
July 2008
August 2014   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00816179 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Diagnostic Endoscopic Exploration for Pancreatic Head Mass
Human Clinical Trial of Diagnostic Transgastric Endoscopic Peritoneoscopy for Staging of Pancreatic Head Mass
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.
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.
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Pancreatic Head Mass
Procedure: Transgastric diagnostic endoscopic peritoneoscopy
Endoscopic abdominal exploration utilizing an endoscopically created gastrotomy.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
11
40
August 2014
August 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00816179
2007C0086
No
Not Provided
Not Provided
Jeffrey Hazey, Ohio State University
Jeffrey Hazey
Natural Orifice Surgery Consortium for Assessment and Research
Principal Investigator: Jeffrey W Hazey, MD OSUMC
Ohio State University
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP