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

NCT ID: NCT02594891

Last Updated: 2016-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2016-02-29

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.

Detailed Description

Since its introduction in 1968, endoscopic retrograde cholangiopancreatography (ERCP) has become a commonly performed endoscopic procedure, and the first choice in the management of choledocholithiasis. Although as an endoscopic minimally invasive procedure, there are still certain complications of ERCP, cholangitis is one of the main complications. In European and American countries, 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. In China endoscopic nasobiliary drainage is usually adopted to prevent post-ERCP cholangitis. Although nose bile duct was more convenient to pull out without endoscope again, but patients often feel nose pharynx ministry unwell obviously. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

endoscopic retrograde biliary drainage

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.

Group Type: EXPERIMENTAL

endoscopic retrograde biliary drainage

Intervention Type: 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 nasobiliary drainage

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.

Group Type: PLACEBO_COMPARATOR

endoscopic nasobiliary drainage

Intervention Type: DEVICE

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

Interventions

endoscopic retrograde biliary drainage

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.

Intervention Type: DEVICE

endoscopic nasobiliary drainage

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First People's Hospital of Hangzhou

OTHER

Sponsor Role: lead

Responsible Party

Jianfeng Yang

Deputy irector

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaofeng Zhang, M.S

Role: STUDY_DIRECTOR

First People's Hospital of Hangzhou

Locations

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 22341094 (View on PubMed)

Other Identifiers

2011-001-004

Identifier Type: -

Identifier Source: org_study_id