Clinical trial · Interventional
Endoscopic Pancreatic Duct Stenting for Relief of Obstructive Pain in Patients With Pancreatic Cancer
Endoscopic Pancreatic Duct Stenting for Relief of Obstructive Pain in Patients: A Prospective Pilot Study
NCT01895790CI-TRIAL-00026277withdrawnPhase 1 / Phase 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): We could not find any candidate eligible for recruitment
Summary
Brief summary (as posted)
This research is being done to assess the effects of pancreatic duct stenting on relief of obstructive pain (pain due to outflow obstruction of main pancreatic duct) caused by pancreatic cancer.
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 |
|---|---|---|---|
| Pancreatic Duct Stent Placement | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pancreatic Duct
- description
- Consecutive adult patients (18-80 years of age) with cytopathologic diagnosis of unresectable pancreatic cancer complaining of pain due to pancreatic duct obstruction will receive a pancreatic duct stent.
- interventionNames
- Device: Pancreatic Duct Stent Placement
Primary outcomes (2)
- measure
- Abdominal pain severity score (Efficacy)
- timeFrame
- 6 months
- description
- The severity of abdominal pain assessed by visual Analog Scale (VAS) score ranging from 0 (no pain)-10 (the most severe pain). This will be measured at baseline (before procedure), and at 1 week, 4 weeks, 12 weeks, and 6 months after procedure
- measure
- Complications (Safety)
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Consecutive adult patients (18-80 years of age) with cytopathologic diagnosis of unresectable pancreatic cancer unresectable pancreatic cancer can be due 1) distant metastasis, 2) involvement of superior mesenteric artery or celiac artery, or 3) if the patient was unfit for surgery due to severe concomitant illness. * Significant biliary obstruction presenting for ERCP. * Significant obstructive-type abdominal pain despite use of opioid analgesics. Obstructive-pain is defined as abdominal pain that is intensified after food intake in the setting of dilated upstream pancreatic duct (\>4mm in diameter). * Ability to give informed consent. Exclusion Criteria: * Unable to give informed consent * Pregnant or breastfeeding women (all women of child-bearing age will undergo urine pregnancy testing) * Estimated life expectancy of 4 weeks or less * Malignant infiltration of the papilla as determined endoscopically or radiographically * Serum bilirubin level ≥ 2 mg/dl (to avoid a confounding variable with respect to the impact of PD stenting on the pain severity and the quality of life; concomitant biliary obstruction should be managed successfully before enrollment) * Acute gastrointestinal bleeding * Coagulopathy defined by prothrombin time \< 50% of control; PTT \> 50 sec, or INR \> 1.5), on chronic anticoagulation, or platelet count \<50,000 * Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other contraindication to endoscopy * Cirrhosis with portal hypertension, varices, and/or ascites
References
Publications (0)
Data not yet available
No reference posted for this study.