Clinical trial NCT03353181: Application of Endoscopic Scissors Cutting ENBD Tube in the Treatment of Malignant Hilar Biliary Strictures
Official title: Application of Endoscopic Scissors Cutting Endoscopic Nasobiliary Drainage Tube in the Treatment of Malignant Hilar Biliary Strictures: a Multicenter, Prospective, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Endoscopic Retrograde Cholangiopancreatography
Klatskin Tumor
Keywords: Endoscopic Retrograde Cholangiopancreatography
endoscopic drainage
endoscopic nasobiliary drainage
stent
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: First People's Hospital of Hangzhou
name: First Affiliated Hospital Xi'an Jiaotong University
name: Fuzhou General Hospital
name: LanZhou University
name: Zhejiang University
name: Chengdu PLA General Hospital
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: General Hospital of Beijing PLA Military Region
name: Dongfang Hospital Beijing University of Chinese Medicine
name: Peking Union Medical College Hospital
name: ShuGuang Hospital
name: Eastern Hepatobiliary Surgery Hospital
name: Xijing Hospital
First posted: 2017-11-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Patients age over 18 and able to tolerate ERCP.
2. Pathologically confirmed inoperable malignant hilar biliary strictures of Bismuth type II to IV.
3. No history of biliary tract surgery and first attempt at endoscopic or percutaneous drainage.
4. No acute cholangitis before ERCP.
5. Informed consent.

Exclusion Criteria:

1. The patient is very ill(Septic shock, sepsis,coagulation disorders and so on) and cannot tolerate endoscopic treatment.
2. Previous biliary drainage procedure.
3. Inability to provide informed consent.
4. Participating in other clinical trials.

Primary outcomes:
measure: occurrence of acute cholangitis
timeFrame: 30 days
Secondary outcomes:
measure: Clinical success
timeFrame: 30 days
measure: Re-intervention
timeFrame: 6 months
Other outcomes:
measure: early adverse
timeFrame: 30 days
Locations:
city: Shanghai
country: China
facility: Department of Gastroenterology, Changhai Hospital, Second Military Medical University
state: Shanghai
Study officials:
affiliation: Changhai Hospital
name: Zhaoshen Li, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Asanuma Y, Andoh H, Tanaka J, Koyama K. [Biliary tract cancer]. Nihon Rinsho. 2001 Nov;59 Suppl 7:301-6. No abstract available. Japanese.