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Failure to recruit patients
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| Name | Class |
|---|---|
| First People's Hospital of Hangzhou | OTHER |
| First Affiliated Hospital Xi'an Jiaotong University | OTHER |
| Fuzhou General Hospital | OTHER |
| LanZhou University |
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The purpose of this study is to evaluate application value of the endoscopic cutting technique in the treatment of malignant hilar biliary strictures.
The management unresectable malignant hilar biliary strictures is still very difficult in spite of the rapid development of new endoscopic devices.The application of stent (plastic or metallic) has allowed us to achieve successful drainage. However,there are many complications related to the placement of stents,such as cholangitis,high rate of re-intervention,and so on. The application of endoscopic cutting technique is considered to reduce these complication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic scissors | Experimental | Endoscopic nasobiliary drainage for malignant hilar biliary strictures at first， and application of endoscopic cutting technique followed. |
|
| Stent | Active Comparator | Standard placement of biliary stent for malignant hilar biliary strictures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic scissors | Device | Application of endoscopic cutting technique following endoscopic nasobiliary drainage in the treatment of malignant hilar biliary strictures. |
|
| Measure | Description | Time Frame |
|---|---|---|
| occurrence of acute cholangitis | Acute cholangitis is defined as cholangitis that occurred within 30 days after endoscopic retrograde cholangiopancreatography(ERCP). | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical success | Clinical success was defined as a decrease in the total bilirubin level to ≤50% of the pretreatment value within 1 week or to ≤75% within 4 weeks. | 30 days |
| Re-intervention | Re-intervention was defined as any type of endoscopic or percutaneous procedure necessary to improve biliary drainage for jaundice or cholangitis after successful placement. |
| Measure | Description | Time Frame |
|---|---|---|
| early adverse | Early adverse event was defined as any ERCP-related adverse event within 4 weeks and a late event was defined as one that occurred after 4 weeks. | 30 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhaoshen Li, M.D | Changhai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology, Changhai Hospital, Second Military Medical University | Shanghai | Shanghai Municipality | 200433 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11822021 | Background | Uchida N, Ezaki T, Fukuma H, Tsutsui K, Kobara H, Bang MH, Ogawa M, Watanabe K, Ono M, Morishita A, Ogi T, Kamata H, Masaki T, Watanabe S, Kuriyama S. Conversion of endoscopic nasobiliary drainage to internal drainage by means of endoscopic scissor forceps. Endoscopy. 2002 Feb;34(2):180. doi: 10.1055/s-2002-19841. No abstract available. | |
| 22895398 |
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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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| OTHER |
| Zhejiang University | OTHER |
| Chengdu PLA General Hospital | OTHER |
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | OTHER |
| General Hospital of Beijing PLA Military Region | OTHER |
| Dongfang Hospital Beijing University of Chinese Medicine | OTHER |
| Peking Union Medical College Hospital | OTHER |
| ShuGuang Hospital | OTHER |
| Eastern Hepatobiliary Surgery Hospital | OTHER |
| Xijing Hospital | OTHER |
Parallel Assignment
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| Biliary stent | Device | Standard placement of biliary stent |
|
| 6 months |
| Kawashima H, Itoh A, Ohno E, Itoh Y, Ebata T, Nagino M, Goto H, Hirooka Y. Preoperative endoscopic nasobiliary drainage in 164 consecutive patients with suspected perihilar cholangiocarcinoma: a retrospective study of efficacy and risk factors related to complications. Ann Surg. 2013 Jan;257(1):121-7. doi: 10.1097/SLA.0b013e318262b2e9. |
| 11808135 | Background | Asanuma Y, Andoh H, Tanaka J, Koyama K. [Biliary tract cancer]. Nihon Rinsho. 2001 Nov;59 Suppl 7:301-6. No abstract available. Japanese. |
| D009370 |
| Neoplasms by Histologic Type |
| D009369 | Neoplasms |