Abdominal Exploration Without Incisions

Jeffrey Hazey

Status and phase: Completed; Early Phase 1

Conditions: Pancreatic Cancer

Treatments: Procedure: Transgastric endoscopic peritoneoscopy.

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00427752

2006H0120

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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20 participants in 1 patient group

Whipple

Experimental group

Description:

Patients with pancreatic cancer who will proceed to a Whipple procedure.

Treatment:

Procedure: Transgastric endoscopic peritoneoscopy.