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NCT Number: NCT03245346

Effects of Epidural Anesthesia and Analgesia on the Prognosis in Patients Undergoing Pancreatic Cancer Surgery

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

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Key information

Conditions

Cancer of Pancreas Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fudan University Shanghai Cancer Center, Shanghai, Shanghai Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Undergoing elective pancreaticoduodenectomy for pancreatic cancer .
  • ASA statusⅠ-Ⅲ.
  • 18 years to 80 years （adults）.
  • Able to understand, communicate and sign an informed consent form.

Exclusion criteria

  • Laparoscopic surgery.
  • Preoperative chemotherapy or radiotherapy.
  • Pregnancy.
  • Allergic to any drugs used during the study.
  • Long-term receiving β-blockers.
  • Complicated with chronic inflammatory diseases, autoimmune diseases, or long-term receiving glucocorticoids or other immunosuppressants before surgery.
  • Abnormal coagulation functions (platelet count prior to surgery <100000/ μL , APTT value is more than the normal value, INR > 1.3 or clopidogrel that cannot be discontinued 7 days prior to surgery).
  • Complicated with severe heart disease (NYHA classification >3), severe renal insufficiency (serum creatinine >1.8mg/dL or receiving renal replacement therapy), severe hepatic disease (Child-Pugh classification

= C), diabetes (fasting blood glucose not in the range of 3.9-13.8 mmol/L ), or acute infectious diseases (WBC>10000/μL) before surgery.

  • BMI > 35.
  • All contraindications to epidural anesthesia and analgesia.
  • Chronic opiate medication/drug abuse.
  • Complicated with severe mental illness, cognitive disorder or unable to collaborate during the study.
  • Refuse to sign an informed consent form.

Treatment and study plan

GEA

Drug

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.

Other names: General anesthesia combined with epidural anesthesia

PCEA

Drug

Patient-controlled epidural analgesia (0.15% ropivacaine infusion) will be provided after surgery.

Other names: Patient-controlled epidural analgesia

GA

Drug

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

Other names: General anesthesia

PCIA

Drug

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

Other names: Patient-controlled intravenous analgesia

Primary outcomes

  1. Overall survival (OS)

    Time frame: During 2 years after surgery

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

Secondary outcomes

  1. Disease-free survival (DFS )

    Time frame: During 2 years after surgery

    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

  2. Postoperative pain score and side effects of patient-controlled analgesia

    Time frame: During the first 48 hours after surgery

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

  3. Incidence of delirium

    Time frame: During the first 1 week after surgery

    Assessed for delirium using the 3D-CAM instrument

  4. Incidence of persistent post-surgical pain (PPSP) after surgery

    Time frame: During 2 years after surgery

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

  5. Length of stay in hospital after surgery and total costs after surgery

    Time frame: During the first 30 days after surgery

  6. Return of bowel function

    Time frame: During the first 30 days after surgery

    Measured by the time of first flatus

  7. Start of enteral tube feeding

    Time frame: During the first 30 days after surgery

    Measured by the time of first enteral tube feeding after surgery

  8. Removal of Perianastomotic drains

    Time frame: During the first 30 days after surgery

  9. Removal of Urinary drainage

    Time frame: During the first 30 days after surgery

  10. Removal of nasogastric tube

    Time frame: During the first 30 days after surgery

  11. Removal of enteral feeding tube

    Time frame: During the first 30 days after surgery

  12. Blood level of neuroendocrine, stress and inflammatory response

    Time frame: During surgery and the first 24 hours after surgery (post-operative day 1)

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

  13. Serum CA19-9 、CA125、CEA、CA72-4、CA242、AFP、CA15-3、CA50 levels

    Time frame: During 2 years after surgery

  14. Plasma levels of ropivacaine and sufentanil

    Time frame: During surgery and the first 24 hours after surgery (post-operative day 1)

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Effects of Epidural Anesthesia and Analgesia on the Prognosis in Patients Undergoing Pancreatic Cancer Surgery: A Multi-center Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2023
Study completion
2025
First posted
Aug 10, 2017
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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