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| Name | Class |
|---|---|
| Washington University School of Medicine | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GEA+PCEA | Experimental | General anesthesia combined with epidural anesthesia will be performed during surgery and patient-controlled epidural analgesia (PCEA) will be provided after surgery. |
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| GA+PCIA | Other | General anesthesia will be performed during surgery and patient-controlled intravenous analgesia (PCIA) will be provided after surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GEA | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Changhong Miao | Contact | +86-021-64175590 | 82420 | miaochh@aliyun.com |
| Xuqin Zhu | Contact | +86-021-64175590 | 82420 | zhuxuqin1101@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Changhong Miao | Fudan University | Principal Investigator |
| Qianjin Liu | Washington University School of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D000767 | Anesthesia, Epidural |
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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| PCEA | Other | Patient-controlled epidural analgesia (0.15% ropivacaine and 0.5ug/ml sufentanil infusion) will be provided after surgery. |
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| GA | Other | General anesthesia will be maintained with inhalation (sevoflurane) and sufentanil infusion, and muscle relaxants will be administered when considered necessary. |
|
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| PCIA | Other | Patient-controlled intravenous analgesia (1ug/ml sufentanil) will be provided after surgery. |
|
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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 |
| Fudan University Zhongshan Hospital | Shanghai | Shanghai Municipality | 200032 | China |
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| Fudan University Huashan Hospital | Shanghai | Shanghai Municipality | 200040 | China |
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |