Advertisement

Topics

The Effect of Different Duration of Bolloon Dilation During ESBD

2016-11-09 09:53:22 | BioPortfolio

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.

Study Design

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

Conditions

Common Bile Duct Stones

Intervention

30" group, 60" group, 180" group

Location

Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai
Shanghai
China
200127

Status

Not yet recruiting

Source

RenJi Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-11-09T09:53:22-0500

Clinical Trials [8326 Associated Clinical Trials listed on BioPortfolio]

Comparison Between Pre and Intraoperative ERCP in Treatment of Common Bile Duct Stones

ERCP plays an important role in management of common bile duct stones. Herein the investigators compare preoperative against intraoperative ERCP. 210 were included but only 198 patients w...

Microbiomes in Patients of Recurrent Common Bile Duct Stones

Bile duct stones is a common biliary tract disease, which is characterized by high morbidity and frequent recurrence. Endoscopic retrograde cholangiopancreatography (ERCP) is an effective ...

Digital SpyGlass Confirmed Common Bile Duct Stones Clearance Without Fluoroscopy

This study aim to evaluated the effectiveness of Digital SpyGlass Cholangioscopy to facilitate common bile duct stone removal without fluoroscopy

Fibrin Sealant for Cholangiotomy Closure Study

Bile leak reduction from the common bile duct, as a result of glue appliance after cholangiotomy.

Endoscopic Treatment of Difficult Bile Duct Stones: Spyglass + EHL x Balloon Dilation of the Papilla

This study compare 2 techniques to treat difficult bile duct stones endoscopically

PubMed Articles [12276 Associated PubMed Articles listed on BioPortfolio]

Efficacy and safety of endoscopic procedures for common bile duct stones in patients aged 85 years or older: A retrospective study.

The Endoscopic procedures for common bile duct (CBD) stones are reportedly safe in the elderly patients. However, the definition of the elderly is different in each report. If the elderly are defined ...

Eversion Bile Duct Anastomosis: A Safe Alternative for Bile Duct Size Discrepancy in Deceased Donor Liver Transplantation.

Introduction Bile duct size discrepancy in liver transplantation may increase the risk of biliary complications. The aim of this study was to evaluate the safety and outcomes of the eversion bile duct...

Modified transprepancreatic septotomy reduces postoperative complications after intractable biliary access.

This study aimed to assess the clinical value of transprepancreatic septotomy indwelling guide wire or pancreatic duct stent in intractable endoscopic retrograde cholangiopancreatography (ERCP) for bi...

Novel use of a balloon dilatation catheter to enable mechanical lithotripsy of difficult common bile duct stones after initial failed attempt: A case report.

Difficult and large common bile duct stones can be crushed and removed using a mechanical lithotripter. Very often the lack of working space within the common bile duct causing the failure of mechanic...

Laparoscopic-endoscopic rendezvous versus preoperative endoscopic sphincterotomy in people undergoing laparoscopic cholecystectomy for stones in the gallbladder and bile duct.

The management of gallbladder stones (lithiasis) concomitant with bile duct stones is controversial. The more frequent approach is a two-stage procedure, with endoscopic sphincterotomy and stone remov...

Medical and Biotech [MESH] Definitions

The largest bile duct. It is formed by the junction of the CYSTIC DUCT and the COMMON HEPATIC DUCT.

Passages external to the liver for the conveyance of bile. These include the COMMON BILE DUCT and the common hepatic duct (HEPATIC DUCT, COMMON).

Tumor or cancer of the COMMON BILE DUCT including the AMPULLA OF VATER and the SPHINCTER OF ODDI.

The duct that is connected to the GALLBLADDER and allows the emptying of bile into the COMMON BILE DUCT.

Diseases of the COMMON BILE DUCT including the AMPULLA OF VATER and the SPHINCTER OF ODDI.

More From BioPortfolio on "The Effect of Different Duration of Bolloon Dilation During ESBD"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Pancreatitis
Pancreatitis Acute pancreatitis is inflammation of the pancreas caused by the release of activated pancreatic enzymes. Common triggers are biliary tract disease and chronic heavy alcohol intake.  Diagnosis is based on clinical presentation...

Infectious-diseases
Antiretroviral Therapy Clostridium Difficile Ebola HIV & AIDS Infectious Diseases Influenza Malaria Measles Sepsis Swine Flu Tropical Medicine Tuberculosis Infectious diseases are caused by pathogenic...


Searches Linking to this Trial