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

Cancer of Pancreas Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03245346
• Other study ID #: FDUSCCA-1
• Status: Recruiting
• Phase: N/A
• Start date: December 19, 2017
• Est. completion date: December 18, 2021

Study information

• Verified date: December 2019
• Source: Fudan University
• Contact: Changhong Miao
• Phone: +86-021-64175590
• Email: miaochh[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. This study will also evaluate the effects of this technique on neuroendocrine, stress and inflammatory response in these patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 540
• Est. completion date: December 18, 2021
• Est. primary completion date: December 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Undergoing elective pancreaticoduodenectomy for pancreatic cancer .

2. ASA status?-?.

3. 18 years to 80 years (adults).

4. Able to understand, communicate and sign an informed consent form.

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 ß-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 anesthesia and analgesia.

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.

Related Conditions & MeSH terms

• Cancer of Pancreas
• Pancreatic Neoplasms

Intervention

Drug:
• GEA
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.
• PCEA
Patient-controlled epidural analgesia (0.15% ropivacaine infusion) will be provided after surgery.
• GA
General anesthesia will be maintained with inhalation (sevoflurane) and sufentanil infusion, and muscle relaxants will be administered when considered necessary.
• PCIA
Patient-controlled intravenous analgesia (1ug/ml sufentanil) will be provided after surgery.

Locations

Country	Name	City	State
China	Fudan University Huashan Hospital	Shanghai	Shanghai
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Fudan University Zhongshan Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Fudan University	Washington University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	Defined and calculated as the time from the date of surgery to death related to all reasons	During 2 years after surgery
Secondary	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	During 2 years after surgery
Secondary	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)	During the first 48 hours after surgery
Secondary	Incidence of delirium	Assessed for delirium using the 3D-CAM instrument	During the first 1 week after surgery
Secondary	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)	During 2 years after surgery
Secondary	Length of stay in hospital after surgery and total costs after surgery		During the first 30 days after surgery
Secondary	Return of bowel function	Measured by the time of first flatus	During the first 30 days after surgery
Secondary	Start of enteral tube feeding	Measured by the time of first enteral tube feeding after surgery	During the first 30 days after surgery
Secondary	Removal of Perianastomotic drains		During the first 30 days after surgery
Secondary	Removal of Urinary drainage		During the first 30 days after surgery
Secondary	Removal of nasogastric tube		During the first 30 days after surgery
Secondary	Removal of enteral feeding tube		During the first 30 days after surgery
Secondary	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)	During surgery and the first 24 hours after surgery (post-operative day 1)
Secondary	Serum CA19-9 ?CA125?CEA?CA72-4?CA242?AFP?CA15-3?CA50 levels		During 2 years after surgery
Secondary	Plasma levels of ropivacaine and sufentanil		During surgery and the first 24 hours after surgery (post-operative day 1)