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The purpose of this study is to evaluate the efficacy of preoperative biliary drainage (PBD) which is performed prior to pancreatoduodenectomy candidates with obstructive jaundice by observing the prevalence of drainage and surgery related complications, hospital stay, medical cost and life quality compared to surgery alone. It is anticipated that PBD can reduce the prevalence of complications and improve the outcome of pancreatoduodenectomy.
Obstructive jaundice is a common symptom in patients with pancreatic head cancer or peri-ampullary cancer. It is regarded that proper surgical resection is the only possible way of radical cure for those patients without evidence of metastasis. Since high preoperative bilirubin level is suggested to be a risk factor for pancreatoduodenectomy, preoperative biliary drainage has been applied to clinical practice to improve the outcome of surgery. However, results from previous studies have inconsistent results showing that PBD may have adverse effect on patients by elevating the prevalence of complications. Since PBD is widely performed worldwide, its value needs to be clarified. Thus the present study is designed to systematically evaluate the value of PBD via recruiting participants who may most likely benefit from PBD. It is anticipated that results from this study can present an instructive conclusion on whether PBD should be performed prior to pancreatoduodenectomy as well as reveal the preferable type of PBD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pancreatoduodenectomy | Active Comparator | Instant pancreatoduodenectomy within one week after diagnosis including: Evaluate the resectability; Remove pancreas head, gastric pyloric antrum, duodenum, distal common bile duct and regional lymph nodes; Reconstruct digestive tract. |
|
| ENBD and Pancreatoduodenectomy | Experimental | Consistent ENBD (Endoscopic Nasobiliary Drainage) for 3 weeks or drainage until bilirubin level decreases to 200μmol per liter or below then perform pancreatoduodenectomy including: Evaluate the resectability; Remove pancreas head, gastric pyloric antrum, duodenum, distal common bile duct and regional lymph nodes; Reconstruct digestive tract. |
|
| EBD and Pancreatoduodenectomy | Experimental | Consistent EBD (Endoscopic Biliary Drainage) for 3 weeks or drainage until bilirubin level decreases to 200μmol per liter or below then perform pancreatoduodenectomy including: Evaluate the resectability; Remove pancreas head, gastric pyloric antrum, duodenum, distal common bile duct and regional lymph nodes; Reconstruct digestive tract. |
|
| PTCD and Pancreatoduodenectomy | Experimental | Consistent PTCD (Percutaneous Transhepatic Cholangial Drainage) for 3 weeks or drainage until bilirubin level decreases to 200μmol per liter or below then perform pancreatoduodenectomy including: Evaluate the resectability; Remove pancreas head, gastric pyloric antrum, duodenum, distal common bile duct and regional lymph nodes; Reconstruct digestive tract. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pancreatoduodenectomy | Procedure |
| ||
| ENBD and Pancreatoduodenectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Infectious Complications | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Hemorrhagic Complications | up to 6 months | |
| Liver Function Evaluation | up to 6 months | |
| Incidence of Bile Leakage |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Incision Complications | up to 3 months | |
| Incidence of Pulmonary Infections | up to 6 months | |
| Incidence of Pleural Effusion |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huai-zhi Wang, M.D., Ph.D. | Contact | 86-23-13996950719 | whuaizhi@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Huai-zhi Wang, M.D., Ph.D. | Southwest Hospital, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institution of Hepatobiliary Surgery, Southwest Hospital | Chongqing | Chongqing Municipality | 400038 | China |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D041781 | Jaundice, Obstructive |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D016577 | Pancreaticoduodenectomy |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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|
| Procedure |
|
| EBD and Pancreatoduodenectomy | Procedure |
|
| PTCD and Pancreatoduodenectomy | Procedure |
|
| up to 6 months |
| Incidence of Pancreatic Leakage | up to 6 months |
| Life Quality Score | up to 12 months |
| Digestive Function Recovery | up to 6 months |
| up to 6 months |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D007565 | Jaundice |
| D006932 | Hyperbilirubinemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |