Application of Endoscopic Scissors Cutting ENBD Tube in the Treatment of Malignant Hilar Biliary Strictures

Endoscopic Retrograde Cholangiopancreatography Clinical Trial

— ENBD  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03353181
• Other study ID #: ENBD-01
• Status: Withdrawn
• Phase: N/A
• Start date: November 30, 2017
• Est. completion date: December 25, 2019

Study information

• Verified date: August 2022
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate application value of the endoscopic cutting technique in the treatment of malignant hilar biliary strictures.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 25, 2019
• Est. primary completion date: September 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endoscopic Retrograde Cholangiopancreatography
• Klatskin Tumor

Intervention

Device:
• Endoscopic scissors
Application of endoscopic cutting technique following endoscopic nasobiliary drainage in the treatment of malignant hilar biliary strictures.
• Biliary stent
Standard placement of biliary stent

Locations

Country	Name	City	State
China	Department of Gastroenterology, Changhai Hospital, Second Military Medical University	Shanghai	Shanghai

Sponsors (14)

Lead Sponsor

Collaborator

Changhai Hospital

Chengdu PLA General Hospital, Dongfang Hospital Beijing University of Chinese Medicine, Eastern Hepatobiliary Surgery Hospital, First Affiliated Hospital Xi'an Jiaotong University, First People's Hospital of Hangzhou, Fuzhou General Hospital, General Hospital of Beijing PLA Military Region, LanZhou University, Peking Union Medical College Hospital, ShuGuang Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Xijing Hospital, Zhejiang University

Country where clinical trial is conducted

China, 

References & Publications (3)

Asanuma Y, Andoh H, Tanaka J, Koyama K. [Biliary tract cancer]. Nihon Rinsho. 2001 Nov;59 Suppl 7:301-6. Review. Japanese. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	occurrence of acute cholangitis	Acute cholangitis is defined as cholangitis that occurred within 30 days after endoscopic retrograde cholangiopancreatography(ERCP).	30 days
Secondary	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
Secondary	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.	6 months