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

NCT05035433 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2021-09-05

No results posted yet for this study

Summary

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.

Conditions

  • Choledocholithiasis
  • Cholangiopancreatography, Endoscopic Retrograde

Interventions

PROCEDURE

First lithotripsy and then EPBD

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 EPBD and then lithotripsy

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.

Sponsors & Collaborators

  • RenJi Hospital

    collaborator OTHER
  • Shanghai Pudong Hospital

    collaborator OTHER
  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Wang Xuefeng, PhD · Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-06
Primary Completion
2023-01-31
Completion
2023-01-31

Countries

  • China

Study Locations

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Read the full study record

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View NCT05035433 on ClinicalTrials.gov