Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Central Nervous System Depressants

All Drugs and Chemicals

Platelet Aggregation Inhibitors

Adjuvants, Anesthesia

Analgesics

Herbal and Botanical

Anesthetics

Ropivacaine

Sevoflurane

Sufentanil

Dsuvia

General anesthesia combined with epidural anesthesia will be performed during surgery and patient-controlled epidural analgesia (PCEA) will be provided after surgery.

General anesthesia will be performed during surgery and patient-controlled intravenous analgesia (PCIA) will be provided after surgery.

Thoracic epidural catheterization will be performed and epidural anesthesia will be maintained with 0.25% ropivacaine during surgery. General anesthesia will be maintained with inhalation (sevoflurane) and muscle relaxants will be administered when considered necessary.

Patient-controlled epidural analgesia (0.15% ropivacaine and 0.5ug/ml sufentanil infusion) will be provided after surgery.

PCEA

General anesthesia will be maintained with inhalation (sevoflurane) and sufentanil infusion, and muscle relaxants will be administered when considered necessary.

Patient-controlled intravenous analgesia (1ug/ml sufentanil) will be provided after surgery.

PCIA

Changhong Miao

Xuqin Zhu

Jing Cang

Yingwei Wang

Qianjin Liu

The purpose of this randomized controlled clinical trial is to investigate the effects of epidural block on overall survival，disease-free survival and recovery in patients with pancreatic cancer undergoing distal pancreatectomy. This study will also evaluate the effects of this technique on neuroendocrine, stress and inflammatory response in these patients.

Effects of Epidural Block on the Prognosis in Patients With Pancreatic Cancer Undergoing Distal Pancreatectomy

Effects of Epidural Block on the Prognosis in Patients With Pancreatic Cancer Undergoing Distal Pancreatectomy----A Multi-center Randomized Controlled Trial

Defined and calculated as the time from the date of surgery to death related to all reasons

Defined and calculated as the time from the date of surgery to the first time of pancreatic cancer recurrence or metastasis or cancer-related death

Assessed with visual analogue score ( 0 is no pain and 10 is the most severe pain)

Assessed for delirium using the 3D-CAM instrument

Changes of blood epinephrine, norepinephrine, cortisol, VEGF, interleukin-6 (IL-6)、interleukin-8 (IL-8), peripheral blood NLR ( neutrophil-lymphocyte ratio)

Washington University School of Medicine

Fudan University

Director of Anesthesiology Department of Fudan University Shanghai Cancer Center

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

Dexamethasone

Glucocorticoids

Dexamethasone acetate

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Patients in this group receive general anesthesia, without epidural block and perioperative dexamethasone. Patient-controlled intravenous analgesia is provided after surgery.

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.

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.

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.

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.

Epidural block

Dexamethasone (10 mg) is administered intravenously before anesthesia induction.

Dong-Xin Wang, MD, PhD

Zhen-Zhen Xu, MD

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.

For dexamethasone administration, all the participants, care providers, investigators, and outcomes assessors are masked. For epidural block, outcome assessors are masked.

Perioperative Epidural Block and Dexamethasone in Pancreatic Cancer Surgery

Effect of Perioperative Epidural Block and Dexamethasone on Outcome of Patients Undergoing Pancreatic Cancer Surgery: a 2×2 Factorial Randomized Controlled Trial

Subjective sleep quality is assessed with a Numeric Rating Scale (NRS, an 11-point scale where 0 indicates the best sleep and 10 the worst sleep).

Pain severity is assessed with a Numeric Rating Scale (NRS, an 11-point scale where 0 indicates no pain and 10 the worst pain).

Rate of postoperative gastrointestinal complications.

Rate of overall postoperative complications.

Length of stay in hospital after surgery.

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.

Rate of hospital readmission within 2 years after surgery.

Cancer progression is evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effects of Epidural Block on the Prognosis in Patients With Pancreatic Cancer Undergoing Distal Pancreatectomy	NCT03659292	Cancer of Pancr...	GEA PCEA GA PCIA	18 Years - 80 Years	Fudan University
Perioperative Epidural Block and Dexamethasone in Pancreatic Cancer Surgery	NCT04025840	Pancreatic Canc... Surgery Epidural Block Dexamethasone Overall Surviva...	Epidural block Dexamethasone	45 Years - 90 Years	Peking University First Hospital
Perioperative Epidural Block and Dexamethasone in Pancreatic Cancer Surgery	NCT04025840	Pancreatic Canc... Surgery Epidural Block Dexamethasone Overall Surviva...	Epidural block Dexamethasone	45 Years - 90 Years	Peking University First Hospital
Perioperative Epidural Block and Dexamethasone in Pancreatic Cancer Surgery	NCT04025840	Pancreatic Canc... Surgery Epidural Block Dexamethasone Overall Surviva...	Epidural block Dexamethasone	45 Years - 90 Years	Peking University First Hospital
Effects of Epidural Block on the Prognosis in Patients With Pancreatic Cancer Undergoing Distal Pancreatectomy	NCT03659292	Cancer of Pancr...	GEA PCEA GA PCIA	18 Years - 80 Years	Fudan University

Spots Global Cancer Trial Database for epidural block