Comparison of Efficacy of Basket and Balloon in the Removal of Pancreatic Duct Stones in Chronic Pancreatitis Under ERCP

NCT05289362 | Unknown DMC

• 1 other identifier: XH202202
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the efficacy of basket and balloon in the removal of pancreatic duct stones under ERCP.

Conditions

Pancreatitis, Chronic; Pancreatic Duct Stone

Keywords

Cholangiopancreatography, Endoscopic Retrograde

Outcome Measures

Primary Outcomes (1)

• clearance rates of pancreatic duct stones

  Clearance rates have been defined as complete, partial, or failure if the proportion of stones cleared was \> 90%, 50% - 90%, or \< 50%, respectively.

  during ERCP procedure

Secondary Outcomes (4)

• timeout rate

  during ERCP procedure

• time taken to completely clear the stone

  during ERCP procedure

• number of times to completely clear the stone

  during ERCP procedure

• post-ERCP complications

  30 days after ERCP procedure

Other Outcomes (1)

• abdominal pain relief rate

  30 days after ERCP procedure

Study Arms (2)

Treating pancreatic duct stones by using baskets

EXPERIMENTAL

ERCP will be performed under conscious sedation with intramuscular administration of diazepam 2.5-5.0 mg and pethidine 25-50 mg. If necessary, Endoscopic Sphincterotomy or Endoscopic Papillary Balloon Dilatation will be performed. A dilating bougie or balloon will be used to dilate the stenosis after sphincterotomy. After that, the basket will be used to remove the stones first, and the balloon will replace the basket after 15 minutes to remove any remaining stones. Finally, the effect of the basket will be evaluated.

Device: Basket group

Treating pancreatic duct stones by using balloons

ACTIVE COMPARATOR

ERCP will be performed under conscious sedation with intramuscular administration of diazepam 2.5-5.0 mg and pethidine 25-50 mg. If necessary, Endoscopic Sphincterotomy or Endoscopic Papillary Balloon Dilatation will be performed. A dilating bougie or balloon will be used to dilate the stenosis after sphincterotomy. After that, the balloon will be used to remove the stones first, and the basket will replace the balloon after 15 minutes to remove any remaining stones. Finally, the effect of the balloon will be evaluated.

Device: Balloon group

Interventions

Basket group DEVICE

Under ERCP, the basket is preferentially used to remove the pancreatic duct stones, and then the balloon is used to evaluate the effect and remove the residual stones.

Treating pancreatic duct stones by using baskets

Balloon group DEVICE

Under ERCP, the balloon is preferentially used to remove the pancreatic duct stones, and then the basket is used to evaluate the effect and remove the residual stones.

Treating pancreatic duct stones by using balloons

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• symptomatic adult patients diagnosed with chronic pancreatitis and pancreatic duct stones;
• stones (≤5 mm in diameter) are located in the main pancreatic duct of the pancreatic head/body with dilation of the proximal pancreatic duct.

You may not qualify if:

• suspected to have malignant tumors;
• history of pancreatic surgery or gastrojejunostomy (Billroth II);
• bile duct stricture secondary to cholangitis or chronic pancreatitis;
• acute pancreatitis exacerbation or acute exacerbation of chronic pancreatitis (including biliary pancreatitis);
• there is a stent in the main pancreatic duct;
• coagulation dysfunction (INR≥1.5 or platelet count≤50×10\^9/L);
• pregnant or breastfeeding women;
• patients who refused to participate in the study.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, 200433, China

Location

Related Publications (2)

• Hao L, Liu Y, Xie T, Wang T, Guo HL, Pan J, Wang D, Bi YW, Ji JT, Xin L, Du TT, Lin JH, Zhang D, Zeng XP, Zou WB, Chen H, Li BR, Liao Z, Cong ZJ, Shi RH, Li ZS, Hu LH. Risk Factors and Nomogram for Pancreatic Stone Formation in Chronic Pancreatitis over a Long-Term Course: A Cohort of 2,153 Patients. Digestion. 2020;101(4):473-483. doi: 10.1159/000500941. Epub 2019 Jun 25.

  PMID: 31238312 BACKGROUND

• Hu L, Sun X, Hao J, Xie T, Liu M, Xin L, Sun T, Liu M, Zou W, Ye B, Liu F, Wang D, Cao N, Liao Z, Li Z. Long-term follow-up of therapeutic ERCP in 78 patients aged 90 years or older. Sci Rep. 2014 May 13;4:4918. doi: 10.1038/srep04918.

  PMID: 24819780 BACKGROUND

MeSH Terms

Conditions

Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Liang-hao Hu, MD

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 13, 2022
• First Posted: March 21, 2022
• Study Start: June 15, 2022
• Primary Completion: July 15, 2022
• Study Completion: March 12, 2023
• Last Updated: February 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)