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Human Clinical Trial of Diagnostic Transgastric Endoscopic Peritoneoscopy for Staging of Pancreatic Head Mass


N/A
18 Years
80 Years
Open (Enrolling)
Both
Pancreatic Head Mass

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Trial Information

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 (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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

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.

Outcome Time Frame:

Intraoperatively

Safety Issue:

Yes

Principal Investigator

Jeffrey W Hazey, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

OSUMC

Authority:

United States: Institutional Review Board

Study ID:

2007C0086

NCT ID:

NCT00816179

Start Date:

July 2008

Completion Date:

December 2013

Related Keywords:

  • Pancreatic Head Mass
  • Pancreatic head mass
  • Pancreatic cancer
  • NOTES
  • Endoscopic peritoneoscopy
  • Whipple
  • palliative gastrojejunostomy
  • Marfan Syndrome

Name

Location
The Ohio State University Medical Center Columbus, Ohio  43210