Impact of Pancreatic Endoscopic Drainage on Exocrine Pancreatic Function in Unresectable Pancreatic Cancer

NCT05244174 | Unknown

• 1 other identifier: 2021-006397-22
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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

Pancreatic Neoplasm Malignant Head Primary; Pancreatic Exocrine Insufficiency

Keywords

pancreas cancer; ERCP; pancreatic exocrine insufficiency; pancreatic stent

Outcome Measures

Primary Outcomes (1)

• Level of Fecal elastase-1

  Evaluation of the efficacy of the endoscopic insertion of biliopancreatic stent compared to biliary stent in the improvement of pancreatic secretion measured by FE-1 test in patients with unresectable pancreatic cancer

  1 month after ERCP

Secondary Outcomes (5)

• Quality of life (QoL)

  At 3 and 6 months after ERCP

• Nutritional status

  At 3 and 6 months after ERCP

• Body weight

  At 3 and 6 months after ERCP

• Survival

  At 6 months

• Prevalence of PEI

  1 month, 3 and 6 months

Study Arms (2)

Biliary stent

ACTIVE COMPARATOR

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.

Device: Pancreatic stent

Biliary and pancreatic stent

EXPERIMENTAL

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

Device: Pancreatic stent

Interventions

Pancreatic stent DEVICE

Insertion of a pancreatic stent during ERCP to improve pancreatic secretion

Biliary and pancreatic stent; Biliary stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Known history of chronic pancreatitis
• Any contraindication for ERCP under deep sedation or impossibility of biliary cannulation.
• 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.

Sponsors & Collaborators

• Hospital Clinico Universitario de Santiago: lead

Study Sites (1)

Daniel de la Iglesia

Santiago de Compostela, A Coruña, 15705, Spain

RECRUITING

MeSH Terms

Conditions

Exocrine Pancreatic Insufficiency; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Endocrine System Diseases

Study Officials

• Enrique Dominguez Munoz, MD

  University Hospital of Santiago de Compostela

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel de la Iglesia Garcia, MD

CONTACT

981951364; danieldelaiglesiagarcia@gmail.com

Paula Otero

CONTACT

981951364

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: One of the collaborator of the study will define which treatment group is assigned each patient (Group A and Group B). Only that investigator and the person who perform the ERCP (care provider) will know to which group is assigned the patient. Patients, investigators and outcome assessor are blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gastroenterology

Model Details: Patients with pancreatic head adenocarcinoma will be randomized to biliary stent placement versus bilio-pancreatic stent placement using the computer-generated total randomization method. The randomization process will be carried out by one of the collaborating researchers who will not participate in the follow-up of patients

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 17, 2022
• Study Start: January 25, 2022
• Primary Completion: November 1, 2023
• Study Completion: May 1, 2024
• Last Updated: March 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)