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Pancreatic CancerPhase 4NCT04025840

Perioperative Epidural Block and Dexamethasone in Pancreatic Cancer Surgery

A Phase 4 study testing Epidural block and Dexamethasone in people with Pancreatic Cancer and Surgery, run by Peking University First Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 90 years
Conditions the study is for
Pancreatic Cancer, Surgery, Epidural Block
What is being tested?
Epidural block and Dexamethasone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
1 siteChina
Study dates
11 Sep 2019to Nov 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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；
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

Other trials in China

About this study

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

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.

Read the detailed description

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.

Being tested
Epidural block, Dexamethasone
Keywords
Pancreatic cancer, Radical resection, Epidural block, Dexamethasone, Overall survival
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Epidural blockOther

    Also called Epidural anesthesia/analgesia

    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.

  • DexamethasoneDrug

    Also called Glucocorticoids

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

Study groups in NCT04025840
Study groupRoleWhat they receive
ControlNo interventionPatients in this group receive general anesthesia, without epidural block and perioperative dexamethasone. Patient-controlled intravenous analgesia is provided after surgery.
Epidural blockExperimentalPatients 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.
Receives: Other: Epidural block
DexamethasoneExperimentalPatients in this group receive dexamethasone (10 mg) before anesthesia induction and general anesthesia, without epidural block. Patient-controlled intravenous analgesia is provided after surgery.
Receives: Drug: Dexamethasone
Epidural block+DexamethasoneExperimentalPatients 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.
Receives: Other: Epidural block; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 2-year overall survival

    2-year overall survival

    Measured: Up to 2 years after surgery.

Secondary outcomes (7)

  1. Postoperative gastrointestinal complications.

    Rate of postoperative gastrointestinal complications.

    Measured: Up to 30 days after surgery.

  2. Overall postoperative complications.

    Rate of overall postoperative complications.

    Measured: Up to 30 days after surgery.

  3. Length of stay in hospital after surgery.

    Length of stay in hospital after surgery.

    Measured: Up to 30 days after surgery.

  4. All-cause 30-day mortality.

    Rate of all-cause 30-day mortality.

    Measured: Up to 30 days after surgery.

  5. 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.

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

  6. Hospital readmission within 2 years after surgery.

    Rate of hospital readmission within 2 years after surgery.

    Measured: Up to 2 years after surgery.

  7. 2-year progression-free survival

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

    Measured: Up to 2 years after surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2019
  2. Study start11 Sep 2019
  3. Primary completion22 Oct 2024
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Factorial
Model description
2×2 factorial trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
260 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04025840
Sponsor's protocol ID
2019-99
Status last verified
Jul 2025
First submitted
16 Jul 2019
Last updated
31 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

    PubMed 30207593

  • Siegel RL, Miller KD, Jemal A. Cancer statistics, 2018. CA Cancer J Clin. 2018 Jan;68(1):7-30. doi: 10.3322/caac.21442. Epub 2018 Jan 4.

    PubMed 29313949

  • Rahib L, Smith BD, Aizenberg R, Rosenzweig AB, Fleshman JM, Matrisian LM. Projecting cancer incidence and deaths to 2030: the unexpected burden of thyroid, liver, and pancreas cancers in the United States. Cancer Res. 2014 Jun 1;74(11):2913-21. doi: 10.1158/0008-5472.CAN-14-0155.

    PubMed 24840647

  • Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.

    PubMed 26808342

  • Chen W, Sun K, Zheng R, Zeng H, Zhang S, Xia C, Yang Z, Li H, Zou X, He J. Cancer incidence and mortality in China, 2014. Chin J Cancer Res. 2018 Feb;30(1):1-12. doi: 10.21147/j.issn.1000-9604.2018.01.01.

    PubMed 29545714

  • Kamisawa T, Wood LD, Itoi T, Takaori K. Pancreatic cancer. Lancet. 2016 Jul 2;388(10039):73-85. doi: 10.1016/S0140-6736(16)00141-0. Epub 2016 Jan 30.

    PubMed 26830752

  • Yeo CJ, Cameron JL. Prognostic factors in ductal pancreatic cancer. Langenbecks Arch Surg. 1998 Apr;383(2):129-33. doi: 10.1007/s004230050104.

    PubMed 9641885

  • Winter JM, Cameron JL, Campbell KA, Arnold MA, Chang DC, Coleman J, Hodgin MB, Sauter PK, Hruban RH, Riall TS, Schulick RD, Choti MA, Lillemoe KD, Yeo CJ. 1423 pancreaticoduodenectomies for pancreatic cancer: A single-institution experience. J Gastrointest Surg. 2006 Nov;10(9):1199-210; discussion 1210-1. doi: 10.1016/j.gassur.2006.08.018.

    PubMed 17114007

  • Heerkens HD, Tseng DS, Lips IM, van Santvoort HC, Vriens MR, Hagendoorn J, Meijer GJ, Borel Rinkes IH, van Vulpen M, Molenaar IQ. Health-related quality of life after pancreatic resection for malignancy. Br J Surg. 2016 Feb;103(3):257-66. doi: 10.1002/bjs.10032. Epub 2015 Nov 19.

    PubMed 26785646

  • Ohtsuka T, Yamaguchi K, Chijiiwa K, Kinukawa N, Tanaka M. Quality of life after pylorus-preserving pancreatoduodenectomy. Am J Surg. 2001 Sep;182(3):230-6. doi: 10.1016/s0002-9610(01)00709-7.

    PubMed 11587683

  • Conroy T, Bachet JB, Ayav A, Huguet F, Lambert A, Caramella C, Marechal R, Van Laethem JL, Ducreux M. Current standards and new innovative approaches for treatment of pancreatic cancer. Eur J Cancer. 2016 Apr;57:10-22. doi: 10.1016/j.ejca.2015.12.026. Epub 2016 Feb 4.

    PubMed 26851397

  • Chae BK, Lee HW, Sun K, Choi YH, Kim HM. The effect of combined epidural and light general anesthesia on stress hormones in open heart surgery patients. Surg Today. 1998;28(7):727-31. doi: 10.1007/BF02484619.

    PubMed 9697266

  • Popping DM, Elia N, Van Aken HK, Marret E, Schug SA, Kranke P, Wenk M, Tramer MR. Impact of epidural analgesia on mortality and morbidity after surgery: systematic review and meta-analysis of randomized controlled trials. Ann Surg. 2014 Jun;259(6):1056-67. doi: 10.1097/SLA.0000000000000237.

    PubMed 24096762

  • Guay J. The effect of neuraxial blocks on surgical blood loss and blood transfusion requirements: a meta-analysis. J Clin Anesth. 2006 Mar;18(2):124-8. doi: 10.1016/j.jclinane.2005.08.013.

    PubMed 16563330

  • Haughom BD, Schairer WW, Nwachukwu BU, Hellman MD, Levine BR. Does Neuraxial Anesthesia Decrease Transfusion Rates Following Total Hip Arthroplasty? J Arthroplasty. 2015 Sep;30(9 Suppl):116-20. doi: 10.1016/j.arth.2015.01.058. Epub 2015 Jun 3.

    PubMed 26077150

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Epidural block and Dexamethasone in people with Pancreatic Cancer and Surgery, run by Peking University First Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2-year overall survival (time frame: Up to 2 years after surgery.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04025840, which also lists 38 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.

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