Effect of Endoscopic Papillary Balloon Dilation on ERCP Complications

NCT02510495 | Completed DMC

• 1 other identifier: ERCP Balloon Dilation
• Study Type: interventional
• Target: 1,920
• Locations: 1 country
• Sites: 15

Brief Summary

The purpose of this study is to determine how different endoscopic papillary balloon dilatation (EPBD) duration time affects the complications after endoscopic retrograde cholangiopancreatography (ERCP) in the treatment of common bile duct stones.

Conditions

Complications

Keywords

Sphincterotomy; Dilatation; Common bile duct; Pancreatitis

Outcome Measures

Primary Outcomes (1)

• Post-ERCP pancreatitis

  Upper abdominal pain with serum amylase elevation no less than 462 U/L after the procedure

  Within 7 days after ERCP

Secondary Outcomes (11)

• Hemorrhage

  Within 7 days after ERCP

• Perforation

  Within 7 days after ERCP

• Acute cholangitis

  Within 7 days after ERCP

• Pain

  Within 7 days after ERCP

• Operation time

  Up to 2 hours

Study Arms (5)

0" group

NO INTERVENTION

After a small sphincterotomy was performed, a controlled radial expansion (CRE) balloon (diameter 8, 9, 10, 11, 12, 13.5, 15; Boston Scientific) was chosen according to the diameter of bile duct. It was placed across the papilla orifice and then gradually filled with diluted contrast in 15 seconds. When the waist disappeared, the balloon was deflated immediately. The stones were then retrieved by a basket or retrieval balloon. Mechanical lithotripsy was used if necessary.

30" group

EXPERIMENTAL

After a small sphincterotomy was performed, a controlled radial expansion (CRE) balloon (diameter 8, 9, 10, 11, 12, 13.5, 15; Boston Scientific) was chosen according to the diameter of bile duct. It was placed across the papilla orifice and then gradually filled with diluted contrast in 15 seconds. When the waist disappeared, the balloon was inflated till 30 seconds prior deflated. The stones were then retrieved by a basket or retrieval balloon. Mechanical lithotripsy was used if necessary.

Procedure: 30" group

60" group

EXPERIMENTAL

After a small sphincterotomy was performed, a controlled radial expansion (CRE) balloon (diameter 8, 9, 10, 11, 12, 13.5, 15; Boston Scientific) was chosen according to the diameter of bile duct. It was placed across the papilla orifice and then gradually filled with diluted contrast in 15 seconds. When the waist disappeared, the balloon was inflated till 60 seconds prior deflated. The stones were then retrieved by a basket or retrieval balloon. Mechanical lithotripsy was used if necessary.

Procedure: 60" group

180" group

EXPERIMENTAL

After a small sphincterotomy was performed, a controlled radial expansion (CRE) balloon (diameter 8, 9, 10, 11, 12, 13.5, 15; Boston Scientific) was chosen according to the diameter of bile duct. It was placed across the papilla orifice and then gradually filled with diluted contrast in 15 seconds. When the waist disappeared, the balloon was inflated till 180 seconds prior deflated. The stones were then retrieved by a basket or retrieval balloon. Mechanical lithotripsy was used if necessary.

Procedure: 180" group

300" group

EXPERIMENTAL

After a small sphincterotomy was performed, a controlled radial expansion (CRE) balloon (diameter 8, 9, 10, 11, 12, 13.5, 15; Boston Scientific) was chosen according to the diameter of bile duct. It was placed across the papilla orifice and then gradually filled with diluted contrast in 15 seconds. When the waist disappeared, the balloon was inflated till 300 seconds prior deflated. The stones were then retrieved by a basket or retrieval balloon. Mechanical lithotripsy was used if necessary.

Procedure: 300" group

Interventions

30" group PROCEDURE

A small sphincterotomy (EST) was performed prior to the EPBD, the length of a small sphincterotomy was considered as no larger than the range which from the orifice to the top one-third of the papilla. a CRE balloon (diameter 8, 9, 10, 11, 12, 13.5, 15; Boston Scientific) was chosen according to the diameter of bile duct. It was placed across the papilla orifice and then gradually filled with diluted contrast in 15 seconds. When the waist disappeared, the balloon was inflated till 30 seconds prior deflated. The stones were then retrieved by a basket or retrieval balloon. Mechanical lithotripsy was used if necessary.

30" group

60" group PROCEDURE

A small sphincterotomy (EST) was performed prior to the EPBD, the length of a small sphincterotomy was considered as no larger than the range which from the orifice to the top one-third of the papilla. a CRE balloon (diameter 8, 9, 10, 11, 12, 13.5, 15; Boston Scientific) was chosen according to the diameter of bile duct. It was placed across the papilla orifice and then gradually filled with diluted contrast in 15 seconds. When the waist disappeared, the balloon was inflated till 60 seconds prior deflated. The stones were then retrieved by a basket or retrieval balloon. Mechanical lithotripsy was used if necessary.

60" group

180" group PROCEDURE

A small sphincterotomy (EST) was performed prior to the EPBD, the length of a small sphincterotomy was considered as no larger than the range which from the orifice to the top one-third of the papilla. a CRE balloon (diameter 8, 9, 10, 11, 12, 13.5, 15; Boston Scientific) was chosen according to the diameter of bile duct. It was placed across the papilla orifice and then gradually filled with diluted contrast in 15 seconds. When the waist disappeared, the balloon was inflated till 180 seconds prior deflated. The stones were then retrieved by a basket or retrieval balloon. Mechanical lithotripsy was used if necessary.

180" group

300" group PROCEDURE

A small sphincterotomy (EST) was performed prior to the EPBD, the length of a small sphincterotomy was considered as no larger than the range which from the orifice to the top one-third of the papilla. a CRE balloon (diameter 8, 9, 10, 11, 12, 13.5, 15; Boston Scientific) was chosen according to the diameter of bile duct. It was placed across the papilla orifice and then gradually filled with diluted contrast in 15 seconds. When the waist disappeared, the balloon was inflated till 300 seconds prior deflated. The stones were then retrieved by a basket or retrieval balloon. Mechanical lithotripsy was used if necessary.

300" group

Eligibility Criteria

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

You may qualify if:

• Age≥18 years
• CBD stone patients, stone diameter≤1.5cm, CBD diameter≤2cm

You may not qualify if:

• Unwillingness or inability to consent for the study
• Coagulation dysfunction (INR\> 1.3) and low peripheral blood platelet count (\<50×109 / L) or using anti-coagulation drugs
• Previous EST or EPBD
• Prior surgery of Bismuth Ⅱ and Roux-en-Y
• Benign or malignant CBD stricture
• Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage, severe liver disease, primary sclerosing cholangitis (PSC), septic shock
• Combined with Mirizzi syndrome and intrahepatic bile duct stones
• Malignant disease
• Biliary-duodenal fistula confirmed during ERCP
• Pregnant women

Sponsors & Collaborators

• Hepatopancreatobiliary Surgery Institute of Gansu Province: lead

Study Sites (15)

Third Military Medical University

Chongqing, Chongqing Municipality, 400038, China

Location

The first hospital of Lanzhou university

Lanzhou, Gansu, 730000, China

Location

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

Location

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

Union hospital,Tongji medical collage,Huazhong University of science and technology

Wuhan, Hubei, 430022, China

Location

Second Xiangya Hospital, Central South University

Changsha, Hunan, 410011, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

Location

The first affiliated hospital of Xi 'an jiaotong university

Xi'an, Shaanxi, 710061, China

Location

Shandong jiaotong Hospital

Jinan, Shandong, 250000, China

Location

Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

Location

Taiyuan Iron and Steel Corporation Hospital

Taiyuan, Shanxi, 030008, China

Location

The First Teaching Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830054, China

Location

The First Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

Tianjin Nankai Hospital

Tianjin, 300100, China

Location

Related Publications (6)

• Meine GC, Baron TH. Endoscopic papillary large-balloon dilation combined with endoscopic biliary sphincterotomy for the removal of bile duct stones (with video). Gastrointest Endosc. 2011 Nov;74(5):1119-26; quiz 1115.e1-5. doi: 10.1016/j.gie.2011.06.042. Epub 2011 Sep 23. No abstract available.

  PMID: 21944309 BACKGROUND

• Tsujino T, Kawabe T, Komatsu Y, Yoshida H, Isayama H, Sasaki T, Kogure H, Togawa O, Arizumi T, Matsubara S, Ito Y, Nakai Y, Yamamoto N, Sasahira N, Hirano K, Toda N, Tada M, Omata M. Endoscopic papillary balloon dilation for bile duct stone: immediate and long-term outcomes in 1000 patients. Clin Gastroenterol Hepatol. 2007 Jan;5(1):130-7. doi: 10.1016/j.cgh.2006.10.013.

  PMID: 17234559 BACKGROUND

• Bang BW, Jeong S, Lee DH, Lee JI, Lee JW, Kwon KS, Kim HG, Shin YW, Kim YS. The ballooning time in endoscopic papillary balloon dilation for the treatment of bile duct stones. Korean J Intern Med. 2010 Sep;25(3):239-45. doi: 10.3904/kjim.2010.25.3.239. Epub 2010 Aug 31.

  PMID: 20830219 BACKGROUND

• Ozaslan E. Comment to "Sixty- versus thirty-seconds papillary balloon dilation after sphincterotomy for the treatment of large bile duct stones: a randomized controlled trial". Dig Liver Dis. 2013 Aug;45(8):700. doi: 10.1016/j.dld.2013.02.004. Epub 2013 Mar 13. No abstract available.

  PMID: 23490342 BACKGROUND

• Liao WC, Lee CT, Chang CY, Leung JW, Chen JH, Tsai MC, Lin JT, Wu MS, Wang HP. Randomized trial of 1-minute versus 5-minute endoscopic balloon dilation for extraction of bile duct stones. Gastrointest Endosc. 2010 Dec;72(6):1154-62. doi: 10.1016/j.gie.2010.07.009. Epub 2010 Sep 25.

  PMID: 20869710 BACKGROUND

• Meng W, Leung JW, Zhang K, Zhou W, Wang Z, Zhang L, Sun H, Xue P, Liu W, Wang Q, Zhang J, Wang X, Wang M, Shao Y, Cai K, Hou S, Li Q, Zhang L, Zhu K, Yue P, Wang H, Zhang M, Sun X, Yang Z, Tao J, Wen Z, Wang Q, Chen B, Shao Q, Zhao M, Zhang R, Jiang T, Liu K, Zhang L, Chen K, Zhu X, Zhang H, Miao L, Wang Z, Li J, Yan X, Wang F, Zhang L, Suzuki A, Tanaka K, Nur U, Weiderpass E, Li X. Optimal dilation time for combined small endoscopic sphincterotomy and balloon dilation for common bile duct stones: a multicentre, single-blinded, randomised controlled trial. Lancet Gastroenterol Hepatol. 2019 Jun;4(6):425-434. doi: 10.1016/S2468-1253(19)30075-5. Epub 2019 Apr 16.

  PMID: 31003961 DERIVED

MeSH Terms

Conditions

Dilatation, Pathologic; Pancreatitis

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pancreatic Diseases; Digestive System Diseases

Study Officials

• Xun Li, M.D., Ph.D.

  Hepatopancreatobiliary Surgery Institute of Gansu Province

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of surgery

Study Record Dates

• First Submitted: July 20, 2015
• First Posted: July 29, 2015
• Study Start: February 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: January 25, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (15)