Application of Endoscopic Scissors Cutting ENBD Tube in the Treatment of Malignant Hilar Biliary Strictures
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate application value of the endoscopic cutting technique in the treatment of malignant hilar biliary strictures.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Endoscopic scissors Endoscopic nasobiliary drainage for malignant hilar biliary strictures at first， and application of endoscopic cutting technique followed. |
Device: Endoscopic scissors
Application of endoscopic cutting technique following endoscopic nasobiliary drainage in the treatment of malignant hilar biliary strictures.
|
| Active Comparator: Stent Standard placement of biliary stent for malignant hilar biliary strictures. |
Device: Biliary stent
Standard placement of biliary stent
|
Outcome Measures
Primary Outcome Measures
- occurrence of acute cholangitis [30 days]
Acute cholangitis is defined as cholangitis that occurred within 30 days after endoscopic retrograde cholangiopancreatography(ERCP).
Secondary Outcome Measures
- Clinical success [30 days]
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.
- Re-intervention [6 months]
Re-intervention was defined as any type of endoscopic or percutaneous procedure necessary to improve biliary drainage for jaundice or cholangitis after successful placement.
Other Outcome Measures
- early adverse [30 days]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients age over 18 and able to tolerate ERCP.
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Pathologically confirmed inoperable malignant hilar biliary strictures of Bismuth type II to IV.
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No history of biliary tract surgery and first attempt at endoscopic or percutaneous drainage.
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No acute cholangitis before ERCP.
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Informed consent.
Exclusion Criteria:
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The patient is very ill(Septic shock, sepsis,coagulation disorders and so on) and cannot tolerate endoscopic treatment.
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Previous biliary drainage procedure.
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Inability to provide informed consent.
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Participating in other clinical trials.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Gastroenterology, Changhai Hospital, Second Military Medical University | Shanghai | Shanghai | China | 200433 |
Sponsors and Collaborators
- Changhai Hospital
- First People's Hospital of Hangzhou
- First Affiliated Hospital Xi'an Jiaotong University
- Fuzhou General Hospital
- LanZhou University
- Zhejiang University
- Chengdu PLA General Hospital
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- General Hospital of Beijing PLA Military Region
- Dongfang Hospital Beijing University of Chinese Medicine
- Peking Union Medical College Hospital
- ShuGuang Hospital
- Eastern Hepatobiliary Surgery Hospital
- Xijing Hospital
Investigators
- Principal Investigator: Zhaoshen Li, M.D, Changhai Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Asanuma Y, Andoh H, Tanaka J, Koyama K. [Biliary tract cancer]. Nihon Rinsho. 2001 Nov;59 Suppl 7:301-6. Review. Japanese.
- 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.
- 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.
- ENBD-01