Effect of 8.5 F Plastic Stent Without Proximal Flap on Prevention of Post-ERCP Cholangitis

NCT02594891 | Completed DMC

• 1 other identifier: 2011-001-004
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

Cholangitis is one of the main complications of endoscopic retrograde cholangiopancreatography (ERCP). Plastic biliary stent was used to prevent the occurrence of post-ERCP cholangitis, but the stent should be taken out 1-2 weeks after ERCP with endoscope again. 8.5 F plastic stent with proximal flap can discharge self-driven from biliary to the gut, it has the advantage of avoiding pulling stent out with endoscope again. The purpose of this study is to explore 8.5 F plastic stent with proximal flap on preventing post-ERCP cholangitis of ERCP in patients with choledocholithiasis.

Conditions

Cholangitis; Complication

Keywords

cholangitis; endoscopic retrograde cholangiopancreatography; complication

Outcome Measures

Primary Outcomes (1)

• Post-ERCP cholangitis

  The rate and severity of post-ERCP cholangitis will compared between two groups.

  three months

Secondary Outcomes (1)

• adverse events

  three months

Study Arms (2)

endoscopic retrograde biliary drainage

EXPERIMENTAL

Patients will undergo endoscopic retrograde biliary drainage (ERBD) with 8.5 F plastic stent with proximal flap when bile duct stones were removed clearly with ERCP. The stent will be taken out with endoscopy three months later if not discharge self-driven.

Device: endoscopic retrograde biliary drainage

endoscopic nasobiliary drainage

PLACEBO COMPARATOR

Patients will undergo endoscopic nasobiliary drainage (ENBD) when bile duct stones were removed clearly with ERCP. The nose bile duct will be pulled out 3-5 days later if no cholangitis occurrence.

Device: endoscopic nasobiliary drainage

Interventions

endoscopic retrograde biliary drainage DEVICE

A 8.5 F plastic stent with proximal flap （XinChang medical instrument co., LTD,Shanghai, China) will be inserted into common bile duct with standard procedure.

endoscopic retrograde biliary drainage

endoscopic nasobiliary drainage DEVICE

A nose bile duct（XinChang medical instrument co., LTD,Shanghai, China) will be inserted into common bile duct with standard procedure.

endoscopic nasobiliary drainage

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Obtention of a written informed consent; Patient with choledocholithiasis; Common bile duct stones are removed clearlly.

You may not qualify if:

• No written informed consent; Combined with acute pancreatitis, acute cholangitis pre-ERCP; Patient under 18 or over 75 years.

Sponsors & Collaborators

• First People's Hospital of Hangzhou: lead

Study Sites (1)

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 31006, China

Location

Related Publications (1)

• ASGE Standards of Practice Committee; Anderson MA, Fisher L, Jain R, Evans JA, Appalaneni V, Ben-Menachem T, Cash BD, Decker GA, Early DS, Fanelli RD, Fisher DA, Fukami N, Hwang JH, Ikenberry SO, Jue TL, Khan KM, Krinsky ML, Malpas PM, Maple JT, Sharaf RN, Shergill AK, Dominitz JA. Complications of ERCP. Gastrointest Endosc. 2012 Mar;75(3):467-73. doi: 10.1016/j.gie.2011.07.010. No abstract available.

  PMID: 22341094 BACKGROUND

MeSH Terms

Conditions

Cholangitis

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Xiaofeng Zhang, M.S

  First People's Hospital of Hangzhou

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy irector

Study Record Dates

• First Submitted: November 1, 2015
• First Posted: November 3, 2015
• Study Start: November 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: May 24, 2016

Record last verified: 2016-05

Locations

CN (1)