Clinical trial · Interventional
Comparing Endoscopic Based Stent Strategy Versus Bypass Surgery in Non-resectable Periampullary Cancer
Endoscopic Strategy Versus Surgical by Pass in Nonresectable Periampullary Cancer
NCT00487851CI-TRIAL-00010031withdrawnPhase 2ClinicalTrials.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Why stopped (as posted): Withdrawn
Summary
Brief summary (as posted)
Randomized study comparing endoscopic stent insertion strategy versus double-bypass surgery in non-resectable periampullary cancer
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Neoplasms | — | UNRESOLVED | — |
| Duodenal Neoplasms | Duodenal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| endoscopic strategy | Procedure | — | UNRESOLVED |
| surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Endoscopic treatment strategy
- interventionNames
- Procedure: endoscopic strategy
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Surgical treatment strategy
- interventionNames
- Procedure: surgery
Primary outcomes (1)
- measure
- Primary outcome consist of a composite score (i.e. number of hospitalizations, episodes of cholangitis, degree of jaundice, other complications requiring therapeutic interventions). Secondary outcome are QoL,hospital stay and health economic burden.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients with a locally advanced periampullary neoplastic process with extrahepatic bile duct obstruction. * The patient tumor burden and general condition should be such that treatment related morbidity and mortality is calculated as "reasonable" and both treatment strategies are considered "applicable". Exclusion Criteria: * Non consent. * The patients' general condition will not tolerate either treatment (strategy). * Previous laparotomy or laparoscopy. * Life expectancy \< 3 months. * Inability to participate (language, social, etc.)
References
Publications (0)
Data not yet available
No reference posted for this study.