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Cancer of PancreasNCT03245346

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

A study testing GEA, PCEA and GA in people with Cancer of Pancreas, run by Fudan University at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Cancer of Pancreas
What is being tested?
GEA, PCEA and GA
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
540 participants
Where
2 sitesChina
Study dates
19 Dec 2017to 24 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

  • Fudan University Zhongshan Hospital

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

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

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.

Being tested
GEA, PCEA, GA, PCIA
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • GEADrug

    Also called General anesthesia combined with epidural anesthesia

    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.

  • PCEADrug

    Also called Patient-controlled epidural analgesia

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

  • GADrug

    Also called General anesthesia

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

  • PCIADrug

    Also called Patient-controlled intravenous analgesia

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

Study groups in NCT03245346
Study groupRoleWhat they receive
GEA+PCEAExperimentalGeneral anesthesia combined with epidural anesthesia will be performed during surgery and patient-controlled epidural analgesia (PCEA) will be provided after surgery.
Receives: Drug: GEA; Drug: PCEA
GA+PCIAOtherGeneral anesthesia will be performed during surgery and patient-controlled intravenous analgesia (PCIA) will be provided after surgery.
Receives: Drug: GA; Drug: PCIA

What is being measured

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

  1. Overall survival (OS)

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

    Measured: During 2 years after surgery

Secondary outcomes (14)

  1. Disease-free survival (DFS )

    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

    Measured: During 2 years after surgery

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

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

    Measured: During the first 48 hours after surgery

  3. Incidence of delirium

    Assessed for delirium using the 3D-CAM instrument

    Measured: During the first 1 week after surgery

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

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

    Measured: During 2 years after surgery

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

    Measured: During the first 30 days after surgery

  6. Return of bowel function

    Measured by the time of first flatus

    Measured: During the first 30 days after surgery

  7. Start of enteral tube feeding

    Measured by the time of first enteral tube feeding after surgery

    Measured: During the first 30 days after surgery

  8. Removal of Perianastomotic drains

    Measured: During the first 30 days after surgery

  9. Removal of Urinary drainage

    Measured: During the first 30 days after surgery

  10. Removal of nasogastric tube

    Measured: During the first 30 days after surgery

  11. Removal of enteral feeding tube

    Measured: During the first 30 days after surgery

  12. Blood level of neuroendocrine, stress and inflammatory response

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

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

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

    Measured: During 2 years after surgery

  14. Plasma levels of ropivacaine and sufentanil

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

Timeline

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

  1. First posted10 Aug 2017
  2. Study start19 Dec 2017
  3. Primary completion30 Jun 2023
  4. Study completion24 Sep 2025

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 N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
540 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03245346
Sponsor's protocol ID
FDUSCCA-1
Status last verified
Dec 2019
First submitted
2 Aug 2017
Last updated
19 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhang H, Qu M, Guo K, Wang Y, Gu J, Wu H, Zhu X, Sun Z, Cata JP, Chen W, Miao C. Intraoperative lidocaine infusion in patients undergoing pancreatectomy for pancreatic cancer: a mechanistic, multicentre randomised clinical trial. Br J Anaesth. 2022 Aug;129(2):244-253. doi: 10.1016/j.bja.2022.03.031. Epub 2022 Jun 11.

    PubMed 35697547

Questions about this trial

What is this clinical trial studying?

A study testing GEA, PCEA and GA in people with Cancer of Pancreas, run by Fudan University at 2 sites 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 14 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: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Overall survival (OS) (time frame: During 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 NCT03245346, which also lists 1 linked publication.

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 19 May 2026.

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