Perioperative Epidural Block And Dexamethasone In Pancreatic Cancer Surgery

Study Overview

Perioperative Epidural Block and Dexamethasone in Pancreatic Cancer Surgery

Pancreatic cancer remains a devastating disease with an average 5-year survival rate of about 3-5%. Previous retrospective studies showed that perioperative epidural block and/or dexamethasone are associated with improved outcome after cancer surgery. This randomized trial aims to investigate the effect of perioperative epidural block and/or dexamethasone on long-term survival in patients following pancreatic cancer surgery.

Pancreatic cancer is the fourth leading cause of cancer-related death in the world, and is estimated to become the second one in 2030. For patients with resectable pancreatic cancer, radical surgery is the first-line therapy. However, the clinical outcomes remain poor even after radical resection, as the incidence of postoperative morbidity is up to 50% and the 5-year survival rate remains below 30%. For patients undergoing major intraabdominal surgery, epidural block may provide advantages by blocking the afferent nociceptive stimuli, providing better pain relief, decreasing opioid consumption, and alleviating stress response. These effects may be helpful in preserving immune function. Some retrospective studies showed that epidural block is associated with delayed cancer recurrence/metastasis and improved survival after cancer surgery. Low-dose dexamethasone is frequently used to prevent postoperative nausea and vomiting. Recent evidences from retrospective studies suggest that perioperative dexamethasone may also affect long-term outcome after cancer surgery. For example, in patients undergoing lung cancer surgery, intraoperative dexamethasone is associated with improved recurrence-free and overall survival. Similar results are also reported in patients after pancreatic cancer surgery. The investigators hypothesize that perioperative epidural block and dexamethasone may improve survival in patients after radical pancreatic surgery. The purpose of this study is to investigate whether perioperative epidural block and/or dexamethasone can improve 2-year survival in patients after pancreatic cancer surgery.

Pancreatic Cancer
Surgery
Epidural Block
Dexamethasone
Overall Survival

OTHER: Epidural block
DRUG: Dexamethasone

2019-99

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-07-16	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-07-05
First Submitted that Met QC Criteria 2019-07-17	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-07-08
First Posted (ACTUAL) 2019-07-19	Results First Posted N/A	Last Verified 2021-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Supportive Care

Allocation:
Randomized

Interventional Model:
Factorial

Masking:
Single

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
NO_INTERVENTION: Control Patients in this group receive general anesthesia, without epidural block and perioperative dexamethasone. Patient-controlled intravenous analgesia is provided after surgery.
EXPERIMENTAL: Epidural block Patients in this group receive combined epidural-general anesthesia (0.375% ropivacaine for epidural block), without perioperative dexamethasone. Patient-controlled epidural analgesia is provided after surgery.	OTHER: Epidural block Epidural block (with 0.375% ropivacaine) is performed during surgery. Patient-controlled epidural analgesia (with a mixture of 0.12% ropivacaine and 0.5 microgram/ml sufentanyl) is provided after surgery. DRUG: Dexamethasone Dexamethasone (10 mg) is administered intravenously before anesthesia induction.
EXPERIMENTAL: Dexamethasone Patients in this group receive dexamethasone (10 mg) before anesthesia induction and general anesthesia, without epidural block. Patient-controlled intravenous analgesia is provided after surgery.	OTHER: Epidural block Epidural block (with 0.375% ropivacaine) is performed during surgery. Patient-controlled epidural analgesia (with a mixture of 0.12% ropivacaine and 0.5 microgram/ml sufentanyl) is provided after surgery. DRUG: Dexamethasone Dexamethasone (10 mg) is administered intravenously before anesthesia induction.
EXPERIMENTAL: Epidural block+Dexamethasone Patients this group receive dexamethasone (10 mg) before anesthesia induction and combined epidural-general anesthesia (0.375% ropivacaine for epidural block). Patient-controlled epidural analgesia is provided after surgery.	OTHER: Epidural block Epidural block (with 0.375% ropivacaine) is performed during surgery. Patient-controlled epidural analgesia (with a mixture of 0.12% ropivacaine and 0.5 microgram/ml sufentanyl) is provided after surgery. DRUG: Dexamethasone Dexamethasone (10 mg) is administered intravenously before anesthesia induction.

Primary Outcome Measures	Measure Description	Time Frame
2-year overall survival	2-year overall survival	Up to 2 years after surgery.

Secondary Outcome Measures	Measure Description	Time Frame
Postoperative gastrointestinal complications.	Rate of postoperative gastrointestinal complications.	Up to 30 days after surgery.
Overall postoperative complications.	Rate of overall postoperative complications.	Up to 30 days after surgery.
Length of stay in hospital after surgery.	Length of stay in hospital after surgery.	Up to 30 days after surgery.
All-cause 30-day mortality.	Rate of all-cause 30-day mortality.	Up to 30 days after surgery.
Quality of life in 1- and 2-year survivors.	Quality of life is assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionaire (EORTC QLQ)-PAN26. It is a 26-item questionnaire that evaluates 9 symptoms and 5 emotional difficulties related to pancreatic cancer. Each item is scaled 0-100. High scores indicate worse symptoms and poorer quality of life.	At the end of the first and second year after surgery.
Hospital readmission within 2 years after surgery.	Rate of hospital readmission within 2 years after surgery.	Up to 2 years after surgery.
2-year progression-free survival	Cancer progression is evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1.	Up to 2 years after surgery.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Dong-Xin Wang, MD, PhD

Phone Number: 86 (10) 83572784

Email: wangdongxin@hotmail.com

Study Contact Backup

Name: Zhen-Zhen Xu, MD

Phone Number: 86 (10) 83572460

Email: zjxvzhenzhen@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
45 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Peking University Cancer Hospital & Institute
The Second Affiliated Hospital of Chongqing Medical University

Investigators

PRINCIPAL_INVESTIGATOR: Dong-Xin Wang, MD, PhD, Peking University First Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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