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The aim of the present study was to compare the effect of unilateral versus bilateral stenting in patients with malignant hilar obstruction.
Cholangiocarcinoma accounts for 3% of all gastrointestinal cancers and is the second commonest primary liver cancer. However only a few patients are suitable for surgical resection and therefore endoscopic biliary drainage is the most used palliative treatment modality for malignant hilar stricture. However, whether one or two stents can benefit the patients most is still to be defined. Numerous retrospective case series reached different conclusion, till now, only one randomized trial compared the effect of unilateral versus bilateral stenting in patients with malignant hilar obstruction, nonetheless, nearly one third of the patients had Bismuth Type I stricture, and one stent is enough for drainage in this situation, therefore, the best drainage strategy for patients with Bismuth Type II or Bismuth Type III malignant hilar obstruction is unknown. The aim of the present study was to compare the effect of unilateral versus bilateral stenting in patients with Bismuth Type II or III malignant hilar obstruction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | patients receiving one stent |
|
| 2 | Active Comparator | patients receiving two stents |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ERCP plus one biliary stent | Procedure | ERCP + one biliary stent insertion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Early complications | 30 days within treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day mortality | 30 days within treatment | |
| Late complications | 30 days after treatment | |
| Median survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhaoshen Li, MD | Contact | 86-21-25070552 | li.zhaoshen@hotmail.com | |
| Yu Bai, MD | Contact | 86-21-25074725 | baiyu1998@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhaoshen Li, MD | Changhai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital, Second Military Medical University | Recruiting | Shanghai | 200433 | China |
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| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D002760 | Cholangiopancreatography, Endoscopic Retrograde |
| ID | Term |
|---|---|
| D002758 | Cholangiography |
| D011860 | Radiography, Abdominal |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
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| ERCP plus two biliary stents | Procedure | ERCP + two biliary stents insertion |
|
|
| From stent insertion to the death of the patient |
| Successful drainage | One month after stent insertion |
| Department of Surgery and Transplant Center | Recruiting | Astrova | Slovakia |
|
| D009369 | Neoplasms |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003938 | Diagnostic Techniques, Digestive System |
| D016145 | Endoscopy, Digestive System |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |