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OpenTrials
Completed

NCT Number: NCT00427752

Abdominal Exploration Without Incisions

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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Disease Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

The Ohio State University Center for Minimally Invasive Surgery

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transgastric endoscopic peritoneoscopy.

Procedure

Exploration of the abdominal area

Primary outcomes

  1. 1) That transgastric endoscopic peritoneoscopy is feasible.

    Time frame: 4/12

Secondary outcomes

  1. That bacterial abdominal contamination is not clinically significant.

    Time frame: 04/11

Sponsors and collaborators

Lead sponsor

Jeffrey Hazey

Other

Collaborators

  • Ethicon Endo-Surgery
  • Stryker Nordic

Registry information

Official study title

Diagnostic Transluminal Endoscopic Peritoneoscopy

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Jan 29, 2007
Registry last updated
May 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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