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

Not Applicable

• Conditions: Cancer of Pancreas
• Interventions: Other: GA; Other: GEA; Other: PCIA; Other: PCEA

• Registration Number: NCT03659292
• Lead Sponsor: Fudan University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2018-09
• Study Start: 2018-09
• Study First Submitted: 2018-09-03
• Study First Submitted QC: 2018-09-03
• Last Update Submitted: 2018-09-03
• Study First Posted: 2018-09-06
• Last Update Posted: 2018-09-06
• Primary Completion: 2022-10
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 540

Inclusion Criteria

1. Undergoing elective distal pancreatectomy for pancreatic cancer .
2. ASA statusⅠ-Ⅲ.
3. 18 years to 80 years （adults）.
4. Able to understand, communicate and sign an informed consent form.

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Exclusion Criteria

1. Laparoscopic surgery.
2. Preoperative chemotherapy or radiotherapy.
3. Pregnancy.
4. Allergic to any drugs used during the study.
5. Long-term receiving β-blockers.
6. Complicated with chronic inflammatory diseases, autoimmune diseases, or long-term receiving glucocorticoids or other immunosuppressants before surgery.
7. 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).
8. 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.
9. BMI > 35.
10. All contraindications to epidural block.
11. Chronic opiate medication/drug abuse.
12. Complicated with severe mental illness, cognitive disorder or unable to collaborate during the study.
13. Refuse to sign an informed consent form.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GA+PCIA	GA	General anesthesia will be performed during surgery and patient-controlled intravenous analgesia (PCIA) will be provided after surgery.
GA+PCIA	PCIA	General anesthesia will be performed during surgery and patient-controlled intravenous analgesia (PCIA) will be provided after surgery.
GEA+PCEA	GEA	General anesthesia combined with epidural anesthesia will be performed during surgery and patient-controlled epidural analgesia (PCEA) will be provided after surgery.
GEA+PCEA	PCEA	General anesthesia combined with epidural anesthesia will be performed during surgery and patient-controlled epidural analgesia (PCEA) will be provided after surgery.

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	During 2 years after surgery	Defined and calculated as the time from the date of surgery to death related to all reasons

Secondary Outcome Measures

Name	Time	Method
Disease-free survival (DFS )	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
Postoperative pain score and side effects of patient-controlled analgesia	During the first 48 hours after surgery	Assessed with visual analogue score ( 0 is no pain and 10 is the most severe pain)
Incidence of delirium	During the first 1 week after surgery	Assessed for delirium using the 3D-CAM instrument
Incidence of persistent post-surgical pain (PPSP) after surgery	During 2 years after surgery	Assessed with visual analogue score ( 0 is no pain and 10 is the most severe pain)
Length of stay in hospital after surgery	During the first 30 days after surgery
Return of bowel function	During the first 30 days after surgery	Measured by the time of first flatus
Removal of Perianastomotic drains	During the first 30 days after surgery
Removal of Urinary drainage	During the first 30 days after surgery
Removal of nasogastric tube	During the first 30 days after surgery
Blood level of neuroendocrine, stress and inflammatory response	During surgery and the first 24 hours after surgery	Changes of blood epinephrine, norepinephrine, cortisol, VEGF, interleukin-6 (IL-6)、interleukin-8 (IL-8), peripheral blood NLR ( neutrophil-lymphocyte ratio)
Blood CA19-9 、CA125、CEA、CA72-4、CA242、AFP、CA15-3、CA50 levels	During 2 years after surgery
Blood levels of ropivacaine and sufentanil	During surgery and the first 24 hours after surgery

Trial Locations

Locations (3)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China

Fudan University Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China

Fudan University Huashan Hospital; 🇨🇳 Shanghai, Shanghai, China