Clinical trial · Interventional
Abdominal Exploration Without Incisions
Diagnostic Transluminal Endoscopic Peritoneoscopy
NCT00427752CI-TRIAL-00006859completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transgastric endoscopic peritoneoscopy. | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Whipple
- description
- Patients with pancreatic cancer who will proceed to a Whipple procedure.
- interventionNames
- Procedure: Transgastric endoscopic peritoneoscopy.
Primary outcomes (1)
- measure
- 1) That transgastric endoscopic peritoneoscopy is feasible.
- timeFrame
- 4/12
Secondary outcomes (1)
- measure
- That bacterial abdominal contamination is not clinically significant.
- timeFrame
- 04/11
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDNarula 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. PMID 18027034
- BACKGROUNDCios 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. PMID 17710490
- BACKGROUNDHazey 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. PMID 17054006
- BACKGROUNDMalik 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. PMID 16865615
- RESULTHazey 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. PMID 17701250