Abdominal Exploration Without Incisions

Early Phase 1CompletedNCT00427752

Jeffrey Hazey20 enrolled

Overview

This study is being conducted to determine whether an endoscope, (a small, flexible tube with a camera mounted on the end) passed down through the throat, through the stomach, and into the abdomen can safely and accurately examine the organs and tissue of the abdomen and take biopsies if needed. We wish to determine if this endoscopic diagnostic route is as efficient as the laparoscopic diagnostic route, which is currently the standard of care.

We propose to investigate the efficacy of transgastric endoscopic peritoneoscopy with endoscopic biopsy in patients undergoing diagnostic laparoscopy and who will require a concurrent gastrotomy for placement of a PEG, gastrojejunostomy or gastric resection. We hypothesize that diagnostic endoscopic peritoneoscopy can be done safely with adequate visualization of the abdominal cavity to direct clinical treatment.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Pancreatic Cancer

Interventions

Transgastric endoscopic peritoneoscopy.PROCEDURE

Exploration of the abdominal area

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pancreatic Cancer undergoing staging laparoscopy * Staging or diagnostic laparoscopy in anyone needing enteral access Exclusion Criteria: * Lack of consent * Intra-abdominal adhesions precluding diagnostic laparoscopy

Locations (1)

The Ohio State University Center for Minimally Invasive Surgery

Columbus, Ohio, United States

Outcomes

Primary Outcomes

1) That transgastric endoscopic peritoneoscopy is feasible.

Time frame: 4/12

Secondary Outcomes

That bacterial abdominal contamination is not clinically significant.

Time frame: 04/11

Data from ClinicalTrials.gov

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