Human Clinical Trial of Diagnostic Transgastric Endoscopic Peritoneoscopy for Staging of Pancreatic Head Mass
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pancreatic Head Mass
- Sponsor
- Jeffrey Hazey
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Endoscopically visualize the abdominal cavity to determine absence or presence of metastatic lesions to successfully stage pancreatic head malignancies and direct surgical treatment.
- Status
- Terminated
- Last Updated
- 11 years ago
Overview
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.
Investigators
Jeffrey Hazey
Associate Professor
Ohio State University
Eligibility 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
Outcomes
Primary Outcomes
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 Outcomes
- Comparison of laparoscopic exploration (retrospectively) to endoscopic exploration.(1 year)
- Ability to obtain peritoneal biopsies when appropriate during transgastric endoscopic procedures.(Intraoperatively)