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To investigate the biliary drainage-related cholangitis and other complications of percutaneous transhepatic biliary drainage (PTBD) in the management of Klatskin tumor (KT) compared with endoscopic biliary drainage (EBD).
Operative treatment combined with preoperative biliary drainage (PBD) has been established as a safe management strategy for KT. Preoperative cholangitis was an independent risk factor for patients undergoing resection for KT. However, controversy exists regarding the preferred technique for PBD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biliary drainage 1 | Experimental | Patients with advanced hilar cholangiocarcinoma need biliary drainage performed Endoscopic Retrograde Cholangiopancreatography (ERCP) drainage |
|
| Biliary drainage 2 | Active Comparator | Patients with advanced hilar cholangiocarcinoma need biliary drainage performed percutaneous transhepatic biliary drainage(PTBD) drainage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ERCP Drainage | Procedure | When advanced Klatskin Tumor patients need biliary drainage, they choose to perform endoscopic drainage after informed consent. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute cholangitis | Acute cholangitis is defined if patients experienced abdominal pain, high fever, or chill after procedure in 2 weeks | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Abdominal pain | Pain score (scores:1-10) | 2 weeks |
| Length of hospital stay | The total time of hospital stay | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xun Li, M.D., Ph. D. | Hepatopancreatobiliary Surgery Institute of Gansu Province | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hepatopancreatobiliary Surgery Institute of Gansu Province | Lanzhou | Gansu | 730000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32010755 | Derived | Ba Y, Yue P, Leung JW, Wang H, Lin Y, Bai B, Zhu X, Zhang L, Zhu K, Wang W, Meng W, Zhou W, Liu Y, Li X. Percutaneous transhepatic biliary drainage may be the preferred preoperative drainage method in hilar cholangiocarcinoma. Endosc Int Open. 2020 Feb;8(2):E203-E210. doi: 10.1055/a-0990-9114. Epub 2020 Jan 22. |
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| ID | Term |
|---|---|
| D002761 | Cholangitis |
| D018285 | Klatskin Tumor |
| ID | Term |
|---|---|
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D018281 | Cholangiocarcinoma |
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| PTBD Drainage | Procedure | When advanced Klatskin Tumor patients need biliary drainage, they choose to perform percutaneous transhepatic biliary drainage after informed consent. |
|
| Overall procedure related complication rate | Pancreatitis, bleeding, perforation, seeding | 6 months |
| D000230 |
| Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |