Abdominal Exploration Without Incisions

Pancreatic Cancer Clinical Trial

Official title:

Diagnostic Transluminal Endoscopic Peritoneoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00427752
• Other study ID #: 2006H0120
• Status: Completed
• Phase: Phase 0
• First received: January 25, 2007
• Last updated: May 3, 2012
• Start date: October 2006
• Est. completion date: January 2012

Study information

• Verified date: May 2012
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• Transgastric endoscopic peritoneoscopy.
Exploration of the abdominal area

Locations

Country	Name	City	State
United States	The Ohio State University Center for Minimally Invasive Surgery	Columbus	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Jeffrey Hazey	Ethicon Endo-Surgery, Stryker Nordic

Country where clinical trial is conducted

United States, 

References & Publications (5)

Cios TJ, Reavis KM, Renton DR, Hazey JW, Mikami DJ, Narula VK, Allemang MT, Davis SS, Melvin WS. Gastrotomy closure using bioabsorbable plugs in a canine model. Surg Endosc. 2008 Apr;22(4):961-6. Epub 2007 Aug 19. — View Citation

Hazey JW, Dunkin BJ, Melvin WS. Changing attitudes toward endolumenal therapy. Surg Endosc. 2007 Mar;21(3):445-8. — View Citation

Hazey JW, Narula VK, Renton DB, Reavis KM, Paul CM, Hinshaw KE, Muscarella P, Ellison EC, Melvin WS. Natural-orifice transgastric endoscopic peritoneoscopy in humans: Initial clinical trial. Surg Endosc. 2008 Jan;22(1):16-20. Epub 2007 Aug 14. — View Citation

Malik A, Mellinger JD, Hazey JW, Dunkin BJ, MacFadyen BV Jr. Endoluminal and transluminal surgery: current status and future possibilities. Surg Endosc. 2006 Aug;20(8):1179-92. Epub 2006 Jul 24. Review. — View Citation

Narula VK, Hazey JW, Renton DB, Reavis KM, Paul CM, Hinshaw KE, Needleman BJ, Mikami DJ, Ellison EC, Melvin WS. Transgastric instrumentation and bacterial contamination of the peritoneal cavity. Surg Endosc. 2008 Mar;22(3):605-11. Epub 2007 Nov 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1) That transgastric endoscopic peritoneoscopy is feasible.		4/12	Yes
Secondary	That bacterial abdominal contamination is not clinically significant.		04/11	Yes