Clinical trial NCT05035433: Effect of the Sequence of Dilatation and Lithotripsy on the Treatment of Choledocholithiasis With ERCP
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Choledocholithiasis
Cholangiopancreatography, Endoscopic Retrograde
Keywords: Choledocholithiasis
Cholangiopancreatography, Endoscopic Retrograde
Lithotripsy
Endoscopic papillary balloon dilation
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: RenJi Hospital
name: Shanghai Pudong Hospital
First posted: 2021-09-05
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. \>18 years of age
2. 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)
3. 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
4. Previous cholecystectomy or planned recent cholecystectomy or liver lobectomy can also be included
5. Subjects voluntarily participate in this study and sign the informed consent

Exclusion Criteria:

1. Coagulation disorders (INR\>1.3) and peripheral blood plate count significantly decreased\<50x10\^9/L
2. Preoperative complicated with acute pancreatitis
3. Preoperative biliary hemorrhage
4. Complicated with severe liver disease and primary sclerosing cholangitis
5. Mirizzi syndrome and intrahepatic bile duct stones
6. Complicated malignant tumor of hepatobiliary and pancreatic system
7. Complicated with obvious stricture of the lower segment of the bile duct
8. intraoperative bile duct duodenal fistula was found
9. Previous EST or EPBD
10. Previous history of gastrointestinal reconstruction surgery 11. Other ERCP contraindications

Primary outcomes:
measure: Lithotomy time
timeFrame: About 20 minutes
measure: Stone residual rate
timeFrame: about 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Wang Xuefeng, PhD
role: STUDY_DIRECTOR
References: