Effect of the Sequence of Dilatation and Lithotripsy on the Treatment of Choledocholithiasis With ERCP

Study Overview
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Brief Summary
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Choledocholithiasis is a common and frequently occurring disease in China, accounting for 15.3%   31.7% of the total cholelithiasis.According to its source, can be divided into primary and secondary choledocholithiasis.For large choledocholithiasis, it is difficult to remove all calculi after dilatation of large diameter balloon or mechanical stone following alone.Therefore, we used the method of balloon dilation combined with mechanical lithotripsy after EST.There are few researches on the sequence of balloon dilation and mechanical lithotripsy at home and abroad, and there is no unified standard. Through the ERCP balloon expansion of duodenal papilla sphincter and mechanical lithotripsy in the treatment of common bile duct calculi in patients with clinical observation, the balloon expansion and mechanical lithotripsy time order of take stone, stone residues rate and the influence of recent complications such as postoperative pancreatitis, ERCP in the treatment of huge stones optimization procedure was formulated.

Official Title
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A Prospective, Multicenter Clinical Study of the Effect of the Order of Dilatation of Papillary Muscle and Mechanical Lithotripsy on the Efficacy and Postoperative Complications of ERCP in the Treatment of Choledocholithiasis.

Conditions
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Choledocholithiasis, Cholangiopancreatography, Endoscopic Retrograde

Intervention / Treatment
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* Procedure: First lithotripsy and then EPBD
* Procedure: First EPBD and then lithotripsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years of age For patients with choledocholithiasis found by MRCP and feasible ERCP lithotomy, the diameter of calculi ≥1cm should be indicated (number of calculi should be indicated >5 or<5) During ERCP, the surgeon determined that the calculi should be removed by combining EPBD and mechanical lithotripsy, and the calculi could be removed by a single ERCP Previous cholecystectomy or planned recent cholecystectomy or liver lobectomy can also be included Subjects voluntarily participate in this study and sign the informed consent Exclusion Criteria: Coagulation disorders (INR>1.3) and peripheral blood plate count significantly decreased<50x10^9/L Preoperative complicated with acute pancreatitis Preoperative biliary hemorrhage Complicated with severe liver disease and primary sclerosing cholangitis Mirizzi syndrome and intrahepatic bile duct stones Complicated malignant tumor of hepatobiliary and pancreatic system Complicated with obvious stricture of the lower segment of the bile duct intraoperative bile duct duodenal fistula was found Previous EST or EPBD Previous history of gastrointestinal reconstruction surgery 11. Other ERCP contraindications

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Experimental: First lithotripsy and then EPBD<br>After successful selective bile duct intubation, contrast agent was injected to measure the thickness of the bile duct and the size of bile duct stones under fluoroscopy. For those meeting the inclusion criteria, sphincterotomy was performed first.Papillary sphincter incision after indwelling godet in bile duct, anti-popular character silk will be crushed stone on top into rubble after biliary tract, broken line to suitable size after the switch to expanding balloon EPBD and further kidney stones, papillary sphincter incision after indwelling godet in bile duct, anti-popular character silk will be crushed stone on top into rubble after biliary tract, broken balloon to suitable size after the switch to expansion, expansion size 10-12 mm, according to the lower bile duct diameter, expansion time of 30 seconds.Then, the stones were removed with a net basket or balloon, and the nasobiliary duct was placed to end the operation. | Procedure: First lithotripsy and then EPBD<br>* After successful selective bile duct intubation, contrast agent was injected to measure the thickness of the bile duct and the size of bile duct stones under fluoroscopy. For those meeting the inclusion criteria, sphincterotomy was performed first.Papillary sphincter incision after indwelling godet in bile duct, anti-popular character silk will be crushed stone on top into rubble after biliary tract, broken line to suitable size after the switch to expanding balloon EPBD and further kidney stones, papillary sphincter incision after indwelling godet in bile duct, anti-popular character silk will be crushed stone on top into rubble after biliary tract, broken balloon to suitable size after the switch to expansion, expansion size 10-12 mm, according to the lower bile duct diameter, expansion time of 30 seconds.Then, the stones were removed with a net basket or balloon, and the nasobiliary duct was placed to end the operation.<br>|
| Experimental: First EPBD and then lithotripsy<br>After puncture of the papillary sphincter, the guide wire was indwelled in the bile duct, and the columnar dilating balloon was inserted in exchange. The dilation size was 10-12mm, and the dilation time was 30 seconds according to the diameter of the lower end of the bile duct.At the end of the expansion, the stones were broken to a suitable size using a one-piece gravel net basket.The calculi were removed by using a stone net basket or balloon, and the nasobiliary duct was placed to end the operation. | Procedure: First EPBD and then lithotripsy<br>* After puncture of the papillary sphincter, the guide wire was indwelled in the bile duct, and the columnar dilating balloon was inserted in exchange. The dilation size was 10-12mm, and the dilation time was 30 seconds according to the diameter of the lower end of the bile duct.At the end of the expansion, the stones were broken to a suitable size using a one-piece gravel net basket.The calculi were removed by using a stone net basket or balloon, and the nasobiliary duct was placed to end the operation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lithotomy time | The time required from completion of papillary myotomy to completion of lithotomy, including the time of cylindrical balloon dilation | About 20 minutes | 
| Stone residual rate | Routine indwelling of the nasobiliary duct was performed, and nasobiliary angiography before removal was performed to confirm the presence of residual stones | about 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Choledocholithiasis, Cholangiopancreatography, Endoscopic Retrograde, Lithotripsy, Endoscopic papillary balloon dilation