Clinical trial · Interventional
Impact of Pancreatic Endoscopic Drainage on Exocrine Pancreatic Function in Unresectable Pancreatic Cancer
Impact of Pancreatic Endoscopic Drainage on Exocrine Pancreatic Function in Patients With Unresectable Pancreatic Adenocarcinoma
- 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)
Background: exocrine pancreatic insufficiency (IPE), frequent in patients with pancreatic cancer, plays a major role in malnutrition and cachexia with a significant impact on survival, quality of life and tumor progression. IPE due to obstruction of the main pancreatic duct and atrophy of pancreatic parenchyma proximal to the tumor could be corrected by insertion of a pancreatic stent for improving nutritional status and consequently survival. Aim: The aim of this study is to assess the impact of transpapilar drainage of the main pancreatic duct on exocrine pancreatic function, nutritional status, and life survival in patients with unresectable pancreatic adenocarcinoma. Methods: Impact of pancreatic endoscopic drainage on exocrine pancreatic function in patients with unresectable pancreatic adenocarcinoma (DEPARA) is a double-blind, prospective, multicentre, international clinical trial. Unresectable locally advanced or metastatic pancreatic cancer (PDAC) will be diagnosed according to the National Comprehensive Cancer Network (NCCN) criteria and the indication of endoscopic retrograde cholangiopancreatography (ERCP) due to obstructive jaundice (\>3mg/dl). PEI will be defined by reduced fecal elastase levels. The nutritional status will be determined by means of Mini-Nutritional Assessment score, sarcopenia score (SARC-F) and laboratory blood tests. Primary aim: Evaluation of the improvement and difference of pancreatic secretion as measured by fecal elastase at 2 weeks post-stenting (biliopancreatic versus biliary). Secondary aims: evaluation of the prevalence of PEI post-stenting (biliopancreatic versus biliary) and proportion of patients normalizing pancreatic function. The difference in terms of weight loss, maldigestion symptoms, GI-Qol, nutricional status and performance status. Survival at 2 weeks, 3 and 6 months, overall survival. Analyzes: fecal elastase value at 2 weeks post-stenting (absolute value of fecal elastase) compared between biliopancreatic stent group and biliary stent group. Discussion: DEPARA will provide insight into the role of pancreatic stents for PEI, malnutrition and progression-free survival in the outcomes of PDAC unresectable.
Conditions
Conditions (2)
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 Exocrine Insufficiency | — | UNRESOLVED | — |
| Pancreatic Neoplasm Malignant Head Primary | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pancreatic stent | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Biliary stent
- description
- Biliary stent by ERCP is indicated both in palliative treatment, because of biliary duct decompression improves patient comfort by decreasing itching and jaundice, as in the treatment of the disease itself, because of it lets reach non-toxic levels of bilirubin which is necessary for chemotherapeutic treatment.
- interventionNames
- Device: Pancreatic stent
- type
- EXPERIMENTAL
- label
- Biliary and pancreatic stent
- description
- During ERCP, the cannulation of the main pancreatic duct may be performed for the placement of a pancreatic duct stent, which is performed routinely as a prophylaxis of post-ERCP acute pancreatitis in patients at risk. In patients with pancreatic cancer, the placement of a pancreatic stent could improve pancreatic secretion by clearing the main pancreatic duct and thus it could improve fat digestion and nutritional status of patients, avoiding the need for PERT
- interventionNames
- Device: Pancreatic stent
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Histological diagnosis of PDAC * Radiological diagnosis of the advanced stage not suitable for upfront surgical resection (either locally advanced or metastatic) * Endoscopic biliary drainage required due to obstructive jaundice * A written consent to participate in the study Exclusion Criteria: * Known history of chronic pancreatitis * Any contraindication for ERCP under deep sedation or impossibility of biliary cannulation. * Inclusion in a clinical trial 4 weeks before this study. * Poor performance status (Eastern Cooperative Oncology Group scale (ECOG) =4) * Known history of gastrointestinal or pancreatic surgery that is associated with alteration of -pancreatic function. * Known history of chronic bowel disease (inflammatory bowel disease) that could be associated with nutrient malabsorption * Gastrointestinal obstruction caused by tumor. * Pregnancy or breastfeeding * Unwillingness or inability to understand the study and sign the consent.
References
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