Impact of Pancreatic Endoscopic Drainage on Exocrine Pancreatic Function in Patients With Unresectable Pancreatic Adenocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Level of Fecal elastase-1
研究概览
简要总结
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.
详细描述
In a recent study by our group, 13 patients with unresectable pancreatic head cancer and PEI were randomized into 2 groups (biliopancreatic stent versus biliary stent), showing a statistically significant improvement in exocrine pancreatic function in favor of biliopancreatic drainage (absolute increase 13C-CRR 23.75% (CI 9.62, 31.74%) vs -1.92% (CI -4.17, 13.92%) p=0.015). All patients who underwent pancreatic drainage showed normalization of pancreatic function and nutritional parameters.
A randomized clinical trial is being conducted in patients with unresecable pancreatic cancer to evaluate the effectiveness of pancreatic stent placement in improving pancreatic secretion by desobstructing the main pancreatic duct and thus improving digestion, nutritional status and consequently patient survival.
HYPOTHESIS:
Transpapillary pancreatic drainage with a pancreatic stent is associated with a significant improvement in pancreatic function, nutritional status, maldigestion symptoms and quality of life in patients with unresectable pancreatic adenocarcinoma who require endoscopic bile duct drainage.
AIM:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Level of Fecal elastase-1
时间窗: 1 month after ERCP
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
次要结局
- Nutritional status(At 3 and 6 months after ERCP)
- Prevalence of PEI(1 month, 3 and 6 months)
- Quality of life (QoL)(At 3 and 6 months after ERCP)
- Body weight(At 3 and 6 months after ERCP)
- Survival(At 6 months)
研究者
J. Enrique Domínguez-Muñoz
Director of Gastroenterology
Hospital Clinico Universitario de Santiago