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2018-09
2022-10
2022-10
540
NCT03659292
Fudan University
Fudan University
INTERVENTIONAL
Effects of Epidural Block on the Prognosis in Patients With Pancreatic Cancer Undergoing Distal Pancreatectomy
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2018-09-03 | N/A | 2018-09-03 |
2018-09-03 | N/A | 2018-09-06 |
2018-09-06 | N/A | 2018-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: GEA+PCEA General anesthesia combined with epidural anesthesia will be performed during surgery and patient-controlled epidural analgesia (PCEA) will be provided after surgery. | OTHER: GEA
OTHER: PCEA
|
| OTHER: GA+PCIA General anesthesia will be performed during surgery and patient-controlled intravenous analgesia (PCIA) will be provided after surgery. | OTHER: GA
OTHER: PCIA
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Incidence of delirium | Assessed for delirium using the 3D-CAM instrument | During the first 1 week after surgery |
| 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 |
| Length of stay in hospital after surgery | During the first 30 days after surgery | |
| Return of bowel function | Measured by the time of first flatus | During the first 30 days after surgery |
| 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 | 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 |
| 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Changhong Miao Phone Number: +86-021-64175590 Email: miaochh@aliyun.com |
Study Contact Backup Name: Xuqin Zhu Phone Number: +86-021-64175590 Email: zhuxuqin1101@sina.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
