The Effect of Different Duration of Bolloon Dilation During ESBD

Common Bile Duct Stones Clinical Trial

Official title:

The Effect of Three Different Duration of Bolloon Dilation During ESBD in the Treatment of Common Bile Duct Stones

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02958618
• Other study ID #: PYZY16-011
• Status: Not yet recruiting
• Phase: N/A
• First received: November 5, 2016
• Last updated: November 5, 2016
• Start date: November 2016
• Est. completion date: December 2018

Study information

• Verified date: November 2016
• Source: RenJi Hospital
• Contact: Li Kewei, M.D., Ph.D.
• Phone: +8613003232119
• Email: keweipig[@]126.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Limited endoscopic sphincterotomy with balloon dilation（ESBD）is a promising technique in treating common bile duct stones. It had the similar success rate of stone extraction, but its incidence of complications remained uncertain. However, there is no clinical evidence and guideline to define the optimal duration of balloon dilation so far. So we designed a prospective randomized trial to compare the effect of three different duration of balloon dilation during ESBD so that we can find the optimal duration of the balloon dilation.

Description:

Common Bile duct stones is one of the most common diseases of which the present incidence is 0.5% -3% in China. Endoscopic sphincterotomy (EST) is the most frequently used endoscopic technique for clearance of stones since the first description in 1974. Although EST is minimally invasive, it brings postoperative complications such as bleeding, perforation and acute pancreatitis. The overall complication and mortality is about 11.7-23% and 0.5%, respectively. Moreover, most believe EST can cause permanent sphincter of Oddi（SO） dysfunction which can result in biliary infection, stone recurrence and malignancies.

As an alternative method to EST, Endoscopic papillary balloon dilation (EPBD) was described by Staritz et al for the management of CBD stones. EPBD can preserve SO function and avoid undesirable effects due to an incompetent sphincter. It is reported that the basic SO function can be restored in one month after EPBD. Nonetheless, EPBD is indicated for the stones smaller than 12mm in diameters because the biliary orifice is enlarged to a lesser extent compared with EST. Furthermore, the incidence of postoperative pancreatitis reaches up to 15-30%. These disadvantages limit the application of EPBD.

As a result, Ersoz et al started a combined technique in 2003, which is called Endoscopic sphincterotomy with balloon dilation（ESBD）. ESBD can preserve SO function, reduce the adverse events, increase the stone removal rate. Especially, it can be applied for the stones larger than 12mm in diameters with large balloon dilatation. When ESBD is being performed, the duration of dilation is one of the most important factors affecting the postoperative complications. Whereas, there are issues regarding this technique that need further evaluation, such as the optimal duration of EPBD after EST. Some believe that short-term dilation can achieve the desired results and the duration of balloon dilation is not significantly correlated with postoperative pancreatitis, while opponents believe that although the small sphincterotomy is performed, short-term dilation has not been able to fully relax the residual sphincter. For long-term complications of ESBD, including the incidence of cholangitis, biliary stones recurrence rate, the incidence of biliary stenosis, there is no relative report either.

This prospective, randomized, controlled trial is designed to compare the difference of efficacy and morbidity among three different duration of balloon dilation（30s，60s，180s） after endoscopic sphincterotomy in the treatment of common bile duct stones. We hope that it will be helpful to establish the reasonable operation guidelines of ESBD.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• CBD stone patients, age=18 years

• Stone diameter=1.5cm

Exclusion Criteria:

• Unwilling to consent for the study

• Previous EST or EPBD

• Prior surgery of Bismuth ? 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

• Pregnant women

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Common Bile Duct Stones
• Gallstones

Intervention

Procedure:
• 30" group
A limited sphincterotomy (EST) was performed prior to the EPBD.The length of the sphincterotomy incision was limited to a third of the size of the papilla. A CRE balloon (diameter 10, 12, 15, 18) was chosen according to the diameter of bile duct. The balloon was then gradually filled with diluted contrast medium under endoscopic and fluoroscopic guidance to observe the disappearance of the waist. Once the waist disappeared, the balloon remained inflated for 30 seconds. The stones were then retrieved by a basket or retrieval balloon. An ENBD catheter (.) was routinely placed into the CBD after stone removal.
• 60" group
A limited sphincterotomy (EST) was performed prior to the EPBD.The length of the sphincterotomy incision was limited to a third of the size of the papilla. A CRE balloon (diameter 10, 12, 15, 18) was chosen according to the diameter of bile duct. The balloon was then gradually filled with diluted contrast medium under endoscopic and fluoroscopic guidance to observe the disappearance of the waist. Once the waist disappeared, the balloon remained inflated for 60 seconds. The stones were then retrieved by a basket or retrieval balloon. An ENBD catheter (.) was routinely placed into the CBD after stone removal.
• 180" group
A limited sphincterotomy (EST) was performed prior to the EPBD.The length of the sphincterotomy incision was limited to a third of the size of the papilla. A CRE balloon (diameter 10, 12, 15, 18 ) was chosen according to the diameter of bile duct. The balloon was then gradually filled with diluted contrast medium under endoscopic and fluoroscopic guidance to observe the disappearance of the waist. Once the waist disappeared, the balloon remained inflated for 180 seconds. The stones were then retrieved by a basket or retrieval balloon. An ENBD catheter (.) was routinely placed into the CBD after stone removal.

Locations

Country	Name	City	State
China	Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-ERCP pancreatitis	Patients with abdominal pain and serum amylase levels more than 3 times the upper limit of normal value. CT scanning is the best diagnostic discriminator	Within 7 days after ESBD	Yes
Secondary	Bleeding	Haematemesis or malena is usually obvious immediately after sphincterotomy, but can be delayed for hours or even for several days.	Within 7 days after ESBD	Yes
Secondary	Perforation	Contrast or air is seen radiologically in the peritoneal cavity or the retroperitoneal region which can be routinely confirmed on CT	Within 7 days after ESBD	Yes
Secondary	Acute cholangitis	Patients typically present with fever, jaundice, and abdominal pain.	Within 7 days after ESBD	Yes
Secondary	Pain	Upper abdominal pain measured by Visual Analogue ScaleScore.	Within 7 days after ERCP	Yes
Secondary	Success rate for clearance of stones	The success of stone removal is verified by the cholangiography after ESBD	Within 72 hours after ERCP	No
Secondary	Pancreatic duct insertion times	Times of the insertion of the duct or the guidewire into the pancreatic duct, no matter the depth	Within 24 hours after ESBD	Yes
Secondary	Operation time	From the insertion of the endoscope to the end of nasobiliary tube fixation	Within 24 hours after ESBD	No
Secondary	Hospital stay	from the admission to the discharge	Up to 30 days	No