Effect of Endoscopic Papillary Balloon Dilation on ERCP Complications

Study Overview
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Brief Summary
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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.

Detailed Description
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Common bile duct (CBD) stone is a common disease with high morbidity. Half century ago, surgery with bile duct exploration and T-tube drainage was the only radical treatment for the stones until a revolutionary technique was reported in 1970, which possible to remove stone by means of endoscopic sphincterotomy (EST) during endoscopic retrograde cholangiopancreatography (ERCP). Since then, EST became a very promising measure for both patients and doctors to meet the purpose of minimally invasive treatment. However, EST remains an advanced technique which requires high skills of the endoscopist. As far as patients who have anatomical biliary abnormalities, such as papillary diverticulum, are more likely to end up with severe complications such as bleeding and perforation during EST procedure. On the other hand, EST may also lead to permanent dysfunction of the Oddi's sphincter. It is currently reported that a growing number of young patients, even some children are managed with EST which is still debated due to the existence of some long-term complications. Endoscopic papillary balloon dilatation (EPBD) is an alternative technique developed to achieve the same purpose as EST but preserving Oddi's sphincter' function partially, and more than that, EPBD is easy to grasp for endoscopist. By using a columnar balloon, Oddi's sphincter can be expanded without direct transection, and the temporary relaxation of Oddi's sphincter makes it possible to remove the stones and the rest of the procedures as well. Removing common bile duct stone by EPBD was firstly reported in 1982 and proved to be safe and efficient. However, clinical observations have been found that simple EPBD has a higher incidence of developing acute pancreatitis after ERCP, especially in patients with intact papilla. The speculated reason for high post-ERCP pancreatitis (PEP) rate might be pancreatic duct orifice edema resulted from inadequate destroy of Oddi's sphincter during a balloon dilatation, leading the pancreatic duct obstructed and high ductal pressure afterward. Retrospective study has indicated the PEP rate of post-EPBD by 10% which was considered slightly higher than ordinary EST before a new modified method has been introduced by a small EST prior to EPBD. Currently small EST plus EPBD has been increasingly used in clinical and proven to be an effective treatment for improving the success rate of the common bile duct stone removal, preserving Oddi's sphincter function and lowering long-term complications. Dedicate practitioners conducted many kinds of studies about reducing post-ERCP complications, and nowadays, some of them focus on the dilation time of EPBD which would be suspected as the key point of the issues. Nonetheless, more institutes are willing to join in EPBD research as the universal concerns for post-ERCP complications increases, no common agreements achieved at present. From some prospected data, we might see confused results. Slowly inject balloon with a contrast agent and keep dilating for 1-2 minutes, until 15 seconds after the image of papilla and balloon waist disappeared is able to get the same stone removal rate as regular procedure does, and a slower balloon filling performance is helpful to protect the Oddi's sphincter function and reduce post-ERCP complications. However, other studies conclude there are no difference no matter in stone removal rate or post-ERCP pancreatitis instead of blood amylase, in which arms are 20 seconds compared 60 seconds and 30 seconds compared 60 seconds. Interestingly, there is another inspiring randomized controlled trial (RCT) study which prolong the dilation time up to 5 minutes. The author figured that PEP rate of five minutes group is smaller than that of the 1-minute group as well as stone removal. Few studies concerning the optimal duration time of EPBD which is very important to patients' safety and maximum utilization of the easier handled EPBD procedure compared to EST. Therefore this large volume multicenter prospective randomize control study targets on how different EPBD duration management affect the complications after ERCP which attempts to discover a promising method for safe therapy in common bile duct stones.

Official Title
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Effect of Different Endoscopic Papillary Balloon Dilation Duration Time on Complications of Common Bile Duct Stone Patient

Conditions
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Complications

Intervention / Treatment
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* Procedure: 30 group
* Procedure: 60 group
* Procedure: 180 group
* Procedure: 300 group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age≥18 years CBD stone patients, stone diameter≤1.5cm, CBD diameter≤2cm Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 0 group<br>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. | |
| Experimental: 30 group<br>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<br>* 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.<br>|
| Experimental: 60 group<br>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<br>* 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.<br>|
| Experimental: 180 group<br>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<br>* 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.<br>|
| Experimental: 300 group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemorrhage | Maintained positive fecal occult blood test appears | Within 7 days after ERCP | 
| Perforation | CT scan shows retroperitoneal space fluid or gas | Within 7 days after ERCP | 
| Acute cholangitis | Intermittent chills and fever after ERCP | Within 7 days after ERCP | 
| Pain | Upper abdominal pain after ERCP measured by Numerical Rating Scale | Within 7 days after ERCP | 
| Operation time | From successful biliary intubation to end of operation | Up to 2 hours | 
| Average hospital stay | Length of stay in hospital | Up to 30 days | 
| Stone clearance rate | The proportion of patients with all stones removed | Up to 2 hours | 
| Success rate of stone extraction in the initial attempt | The proportion of patients with all stones removed in first attempt after EPBD | Up to 2 hours | 
| Rate of mechanical lithotripsy | The proportion of patients whose stones need mechanical lithotripsy before removed | Up to 2 hours | 
| X-ray exposure time | The total radiography time during ERCP | Up to 2 hours | 
| Pancreatic duct insertion times | Times of any accessories goes into the pancreatic duct, no matter how depth | Up to 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sphincterotomy, Dilatation, Common bile duct, Pancreatitis