Clinical trial NCT00427752: Abdominal Exploration Without Incisions
Official title: Diagnostic Transluminal Endoscopic Peritoneoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pancreatic Cancer
Keywords: Transgastric
Endoluminal
Peritoneoscopy
Diagnostic
Feasibility
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Stryker Nordic
name: Ethicon Endo-Surgery
First posted: 2007-01-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 1) That transgastric endoscopic peritoneoscopy is feasible.
timeFrame: 4/12
Secondary outcomes:
measure: That bacterial abdominal contamination is not clinically significant.
timeFrame: 04/11
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Center for Minimally Invasive Surgery
state: Ohio
Study officials:
affiliation: Ohio State University
name: Jeffrey W Hazey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: William S Melvin, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1007/s00464-007-9661-6. Epub 2007 Nov 20.
citation: 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. doi: 10.1007/s00464-007-9530-3. Epub 2007 Aug 19.
citation: Hazey JW, Dunkin BJ, Melvin WS. Changing attitudes toward endolumenal therapy. Surg Endosc. 2007 Mar;21(3):445-8. doi: 10.1007/s00464-006-9001-2.
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. doi: 10.1007/s00464-005-0711-7. Epub 2006 Jul 24.
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. doi: 10.1007/s00464-007-9548-6. Epub 2007 Aug 14.