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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03659292
Other study ID # FDUSCCA-2
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2018
Est. completion date October 2022

Study information

Verified date September 2018
Source Fudan University
Contact Changhong Miao
Phone +86-021-64175590
Email miaochh@aliyun.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 540
Est. completion date October 2022
Est. primary completion date October 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

1. Undergoing elective distal pancreatectomy 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 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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 and 0.5ug/ml sufentanil 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 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 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 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
Secondary Blood CA19-9 ?CA125?CEA?CA72-4?CA242?AFP?CA15-3?CA50 levels During 2 years after surgery
Secondary Blood levels of ropivacaine and sufentanil During surgery and the first 24 hours after surgery
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