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

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Primary Purpose

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

First lithotripsy and then EPBD

First EPBD and then lithotripsy

About this trial

This is an interventional treatment trial for Choledocholithiasis focused on measuring Choledocholithiasis, Cholangiopancreatography, Endoscopic Retrograde, Lithotripsy, Endoscopic papillary balloon dilation

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Xinhua Hospital, Affiliated to Shanghai Jiao Tong University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

First lithotripsy and then EPBD

First EPBD and then lithotripsy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Lithotomy time

The time required from completion of papillary myotomy to completion of lithotomy, including the time of cylindrical balloon dilation

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05035433

First Posted

July 3, 2021

Last Updated

September 2, 2021

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Collaborators

RenJi Hospital, Shanghai Pudong Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05035433

Brief Title

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

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Unknown status

Study Start Date

September 6, 2020 (Actual)

Primary Completion Date

January 2023 (Anticipated)

Study Completion Date

January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Collaborators

RenJi Hospital, Shanghai Pudong Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Choledocholithiasis, Cholangiopancreatography, Endoscopic Retrograde

Keywords

Choledocholithiasis, Cholangiopancreatography, Endoscopic Retrograde, Lithotripsy, Endoscopic papillary balloon dilation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

First lithotripsy and then EPBD

Arm Type

Experimental

Arm Description

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.

Arm Title

First EPBD and then lithotripsy

Arm Type

Experimental

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

First lithotripsy and then EPBD

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

First EPBD and then lithotripsy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Lithotomy time

Description

The time required from completion of papillary myotomy to completion of lithotomy, including the time of cylindrical balloon dilation

Time Frame

About 20 minutes

Title

Stone residual rate

Description

Routine indwelling of the nasobiliary duct was performed, and nasobiliary angiography before removal was performed to confirm the presence of residual stones

Time Frame

about 2 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wang Xuefeng, PhD

Phone

13601833209

Email

wangxuefeng@xinhuamed.com.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Weng Hao, PhD

Phone

15000564124

Email

wenghao@xinhuamed.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wang Xuefeng, PhD

Organizational Affiliation

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Official's Role

Study Director

Facility Information:

Facility Name

Xinhua Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine

City

Shanghai

State/Province

Shanghai

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Weng Hao, PhD

Phone

15000564124

Email

wenghao@xinhuamed.com.cn

Choledocholithiasis, Cholangiopancreatography, Endoscopic Retrograde

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial