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Cholangiocarcinoma (CCA) is the most common biliary tract malignancy and the second most common primary hepatic malignancy. The prognosis of CCA is dismal. Surgery is the only potentially curative treatment, but the majority of patients present with advanced stage disease, and recurrence after resection is common. It is classified into intrahepatic (iCCA), perihilar (pCCA), and distal (dCCA) subtypes. Among all, pCCA is the most common subtype.
This is a prospective, randomized, controlled multicenter trial with two treatment arms, three dimension laparoscopic approach versus open approach. The trial hypothesis is that three dimension laparoscopic surgery has advantages in postoperative recoveries and be equivalent in operation time, oncological results and long-term follow-up compared with open counterpart. The duration of the entire trial is two years including prearrangement, follow-up and analyses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D approach | Experimental | Three dimensional laparoscopic resection for pCCA |
|
| open approach | Experimental | Open resection for pCCA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Three dimensional laparoscopic resection for pCCA | Procedure | Three dimensional laparoscopic resection for pCCA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Mortality was defined as any death that occurred in the 30 days after surgery or during the hospital stay. | 24 months |
| Length of Stay | Length of stay was defined as the postoperative time interval in days. | 24 months |
| R0 Resection Rate | Negative margin rate. | 24 months |
| Bile leakage | The drain bilirubin was monitored after surgery, any elevation for the bilirubin level or the diagnostic puncture proved bile fluid in abdominal cavity. | 24 months |
| TNM Staging | According to AJCC guideline, each patients TNM staging were recorded. | 24 months |
| Complication rate | Complication Rate Measure Description Any complication mentioned in the protocol should be carefully record and analyzed, including postoperative hemorrhage, postoperative pancreatic fistula, etc. | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital | Not yet recruiting | Wuhan | Hubei | 430000 | China |
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| ID | Term |
|---|---|
| D018285 | Klatskin Tumor |
| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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| ID | Term |
|---|---|
| C075943 | 6-propylchromone-2-carboxylic acid |
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| Open resection for pCCA | Procedure | Open resection for pCCA |
|
| Tongji Hospital | Recruiting | Wuhan | Hubei | China |
|
| D009370 |
| Neoplasms by Histologic Type |
| D009369 | Neoplasms |