Clinical trial · Interventional
Endoscopic Evaluation of Premalignant Lesions in the Biliary Tract and Pancreatic Ducts
NCT02057146CI-TRIAL-00070761completedN/AClinicalTrials.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)
Single operater pancreatico-cholangioscopy is performed through the working channel of conventional duodenoscopes. A visual evaluation of the biliary and pancreatic ductal systems is completed and obvious or suspicious macroscopic lesions are targeted by biopsy forceps. Evaluation of the usefulness of probe based confocal laser endomicroscopy in the evaluation of suspected premalignant lesions in the biliary duct and in the pancreas.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Neoplasm of Liver and/or Biliary Ducts | — | UNRESOLVED | — |
| Benign Neoplasms of the Pancreas | Benign Pancreatic Neoplasm | ALIAS | 0.90 |
| Neoplasm of Uncertain Behavior of Biliary System | — | UNRESOLVED | — |
| Neoplasms of the Pancreas | Pancreatic Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Duodenoscopy, pancreatoscopy, cholangioscopy, confocal microscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Mother-baby endoscopy
- description
- Spyglass mother-baby endoscopy in conjunction with ERCP
- interventionNames
- Procedure: Duodenoscopy, pancreatoscopy, cholangioscopy, confocal microscopy
Primary outcomes (1)
- measure
- Accuracy of single operator endoscopy plus pCLE in the biliary and pancreatic ductal system diagnosing premalignant and malignant lesions.
- timeFrame
- Two years
- description
- Beside the safety, technical feasibility and efficacy, we will record and calculate the diagnostic accuray by comparing the outcome of Spyglass/pCLE (endoscopic judgement) with histology (biopsy) and eventual surgical pathology. Outcome measures will be 1) diagnosis of malignant/suspicious lesion by Spyglass and/or pCLE versus final diagnosis with biopsy (Spyglass, other) and/or surgical pathology (resection).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 95 Years
Show eligibility criteria text
Inclusion Criteria: * Suspicious lesions of the hepatobiliary pancreatic duct systems. Exclusion Criteria: * Unwillingness to participate * Unfit for the investigation
References
Publications (3)
- BACKGROUNDArnelo U, Albiin N, Enochsson L, Meisner S, Permert J, Lundell L. Endoscopic evaluation of the pancreatic duct system: opportunities offered by novel technology. Scand J Gastroenterol. 2007 Aug;42(8):1018-20. doi: 10.1080/00365520601101526. PMID 17613934
- RESULTArnelo U, Valente R, Scandavini CM, Halimi A, Mucelli RMP, Rangelova E, Svensson J, Schulick RD, Torphy RJ, Fagerstrom N, Moro CF, Vujasinovic M, Matthias Lohr J, Del Chiaro M. Intraoperative pancreatoscopy can improve the detection of skip lesions during surgery for intraductal papillary mucinous neoplasia: A pilot study. Pancreatology. 2023 Sep;23(6):704-711. doi: 10.1016/j.pan.2023.06.006. Epub 2023 Jun 12. PMID 37336668
- RESULTLohr JM, Lonnebro R, Stigliano S, Haas SL, Swahn F, Enochsson L, Noel R, Segersvard R, Del Chiaro M, Verbeke CS, Arnelo U. Outcome of probe-based confocal laser endomicroscopy (pCLE) during endoscopic retrograde cholangiopancreatography: A single-center prospective study in 45 patients. United European Gastroenterol J. 2015 Dec;3(6):551-60. doi: 10.1177/2050640615579806. PMID 26668748