Clinical trial · Interventional
Diagnostic Endoscopic Exploration for Pancreatic Head Mass
Human Clinical Trial of Diagnostic Transgastric Endoscopic Peritoneoscopy for Staging of Pancreatic Head Mass
NCT00816179CI-TRIAL-00015969terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Helical CT scans at our institution preclude the necessity for diagnostic laparoscopy in most cases at our institution.
Summary
Brief summary (as posted)
This study is being done to find out if an endoscope passed down the throat, through the stomach, and into the abdomen can quickly and accurately examine the organs and tissue of the abdomen and take biopsies if needed.
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 Head Mass | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transgastric diagnostic endoscopic peritoneoscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Endoscopically visualize the abdominal cavity to determine absence or presence of metastatic lesions to successfully stage pancreatic head malignancies and direct surgical treatment.
- timeFrame
- Intraoperatively
Secondary outcomes (2)
- measure
- Comparison of laparoscopic exploration (retrospectively) to endoscopic exploration.
- timeFrame
- 1 year
- measure
- Ability to obtain peritoneal biopsies when appropriate during transgastric endoscopic procedures.
- timeFrame
- Intraoperatively
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age range 18-80 * Radiographic diagnosis of resectable pancreatic head mass presumed to be pancreatic adenocarcinoma Exclusion Criteria: * Inability to obtain informed consent * Pregnancy * Intra-abdominal adhesions that preclude endoscopy * Contraindication to upper endoscopy such as stricture, stenosis of the foregut * Previous gastric surgery * Diagnosis of pancreatic body or tail tumor * History or current diagnosis of gastric ulcer * Metastatic disease diagnosed by CT, EUS, MRI, or nuclear imaging * Patient is not a candidate for resection based upon CT, EUS, MRI, or nuclear imaging * Antiplatelet medication not stopped at least 7 days prior to procedure * Anticoagulant medication not stopped at least 5 days prior to procedure
References
Publications (20)
- BACKGROUNDRattner D, Kalloo A; ASGE/SAGES Working Group. ASGE/SAGES Working Group on Natural Orifice Translumenal Endoscopic Surgery. October 2005. Surg Endosc. 2006 Feb;20(2):329-33. doi: 10.1007/s00464-005-3006-0. No abstract available. PMID 16402290
- BACKGROUNDWhite R, Winston C, Gonen M, D'Angelica M, Jarnagin W, Fong Y, Conlon K, Brennan M, Allen P. Current utility of staging laparoscopy for pancreatic and peripancreatic neoplasms. J Am Coll Surg. 2008 Mar;206(3):445-50. doi: 10.1016/j.jamcollsurg.2007.09.021. Epub 2007 Nov 26. PMID 18308214
- BACKGROUNDLillemoe KD, Cameron JL, Hardacre JM, Sohn TA, Sauter PK, Coleman J, Pitt HA, Yeo CJ. Is prophylactic gastrojejunostomy indicated for unresectable periampullary cancer? A prospective randomized trial. Ann Surg. 1999 Sep;230(3):322-8; discussion 328-30. doi: 10.1097/00000658-199909000-00005. PMID 10493479
- BACKGROUNDPonsky JL. Gastroenterologists as surgeons: what they need to know. Gastrointest Endosc. 2005 Mar;61(3):454. doi: 10.1016/s0016-5107(04)02632-x. No abstract available. PMID 15758924
- BACKGROUNDWagh MS, Merrifield BF, Thompson CC. Endoscopic transgastric abdominal exploration and organ resection: initial experience in a porcine model. Clin Gastroenterol Hepatol. 2005 Sep;3(9):892-6. doi: 10.1016/s1542-3565(05)00296-x. PMID 16234027
- BACKGROUNDMerrifield BF, Wagh MS, Thompson CC. Peroral transgastric organ resection: a feasibility study in pigs. Gastrointest Endosc. 2006 Apr;63(4):693-7. doi: 10.1016/j.gie.2005.11.043. PMID 16564875
- BACKGROUNDKalloo AN, Singh VK, Jagannath SB, Niiyama H, Hill SL, Vaughn CA, Magee CA, Kantsevoy SV. Flexible transgastric peritoneoscopy: a novel approach to diagnostic and therapeutic interventions in the peritoneal cavity. Gastrointest Endosc. 2004 Jul;60(1):114-7. doi: 10.1016/s0016-5107(04)01309-4.