Perioperative Epidural Block and Dexamethasone in Pancreatic Cancer Surgery

NCT04025840 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: 2019-99
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cancer; Surgery; Epidural Block; Dexamethasone; Overall Survival

Keywords

Pancreatic cancer; Radical resection; Epidural block; Dexamethasone; Overall survival

Outcome Measures

Primary Outcomes (1)

• 2-year overall survival

  2-year overall survival

  Up to 2 years after surgery.

Secondary Outcomes (7)

• Postoperative gastrointestinal complications.

  Up to 30 days after surgery.

• Overall postoperative complications.

  Up to 30 days after surgery.

• Length of stay in hospital after surgery.

  Up to 30 days after surgery.

• All-cause 30-day mortality.

  Up to 30 days after surgery.

• Quality of life in 1- and 2-year survivors.

  At the end of the first and second year after surgery.

Other Outcomes (4)

• Subjective sleep quality: Numeric Rating Scale

  Between 8-10 am on the first, second, and third days after surgery.

• Pain severity (at rest and with movement): Numeric Rating Scale

  Between 8-10 am on the first, second, and third days after surgery.

• Time to ambulation after surgery.

  Up to 30 days after surgery.

Study Arms (4)

Control

NO INTERVENTION

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

Epidural block

EXPERIMENTAL

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

Dexamethasone

EXPERIMENTAL

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.

Drug: Dexamethasone

Epidural block+Dexamethasone

EXPERIMENTAL

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; Drug: Dexamethasone

Interventions

Epidural block OTHER

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.

Also known as: Epidural anesthesia/analgesia

Epidural block; Epidural block+Dexamethasone

Dexamethasone DRUG

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

Also known as: Glucocorticoids

Dexamethasone; Epidural block+Dexamethasone

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥45 and \<90 years;
• Clinically diagnosed as resectable or possibly resectable pancreatic cancer and scheduled to undergo radical surgery;
• Agreed to receive epidural block and postoperative patient-controlled analgesia;
• Agreed to participate in the study and provided written informed consent.

You may not qualify if:

• Clinical evidence of unresectable pancreatic cancer or plan to undergo biopsy;
• Previous surgery for pancreatic cancer, scheduled to undergo resurgery for recurrence or metastasis;
• Complicated with primary malignant tumor in other organ(s), either previously or at present;
• Complicated with autoimmune diseases, receiving either glucocorticoids or other immunosuppressants before surgery;
• Unable to complete preoperative evaluation due to severe dementia, language barrier, coma, or end-stage diseases;
• Severe hepatic dysfunction (Child-Pugh C), severe renal insufficiency (serum creatinine \>442 µmol/L or requirement of renal replacement therapy), or American Society of Anesthesiologists classification ≥V；
• Contradictions to epidural anesthesia, including spinal malformation, history of spinal surgery, coagulation disorder, suspected infection at the site of puncture, or severe low back pain;
• Other conditions that are considered unsuitable for study participation;
• Refused to participate in the study.

Sponsors & Collaborators

• Peking University First Hospital: lead
• Peking University Cancer Hospital & Institute: collaborator
• The Second Affiliated Hospital of Chongqing Medical University: collaborator

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

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MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Anesthesia, Epidural; Analgesia; Dexamethasone; Glucocorticoids

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: For dexamethasone administration, all the participants, care providers, investigators, and outcomes assessors are masked. For epidural block, outcome assessors are masked.
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Department of Anaesthesiology and Critical Care Medicine

Model Details: 2×2 factorial trial

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 19, 2019
• Study Start: September 11, 2019
• Primary Completion: October 22, 2024
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)