Diagnostic Endoscopic Exploration for Pancreatic Head Mass

Not Applicable

Terminated

• Conditions: Pancreatic Head Mass

• Registration Number: NCT00816179
• Lead Sponsor: Jeffrey Hazey

Brief Summary

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.

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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-12-30
• Study First Submitted QC: 2008-12-30
• Study First Posted: 2008-12-31
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-30
• Last Update Posted: 2014-11-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Endoscopically visualize the abdominal cavity to determine absence or presence of metastatic lesions to successfully stage pancreatic head malignancies and direct surgical treatment.	Intraoperatively

Secondary Outcome Measures

Name	Time	Method
Comparison of laparoscopic exploration (retrospectively) to endoscopic exploration.	1 year
Ability to obtain peritoneal biopsies when appropriate during transgastric endoscopic procedures.	Intraoperatively

Trial Locations

Locations (1)

The Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States