Diagnostic Endoscopic Exploration for Pancreatic Head Mass

Jeffrey Hazey11 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Pancreatic Head Mass

Interventions

Transgastric diagnostic endoscopic peritoneoscopyPROCEDURE

Endoscopic abdominal exploration utilizing an endoscopically created gastrotomy.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

The Ohio State University Medical Center

Columbus, Ohio, United States

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.

Time frame: 1 year

Ability to obtain peritoneal biopsies when appropriate during transgastric endoscopic procedures.

Time frame: Intraoperatively

Data from ClinicalTrials.gov

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