search
Back to results

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

Primary Purpose

Pancreatitis, Chronic, Pancreatic Duct Stone

Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Basket group
Balloon group
Sponsored by
Changhai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatitis, Chronic focused on measuring Cholangiopancreatography, Endoscopic Retrograde

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Changhai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treating pancreatic duct stones by using baskets

Treating pancreatic duct stones by using balloons

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

timeout rate
Basket or balloon cannot completely remove stones in the targeted area of the pancreatic duct within 15 minutes.
time taken to completely clear the stone
The time taken by the basket or balloon to completely clear the stones in the targeted area of the pancreatic duct.
number of times to completely clear the stone
The number of attempts made by the basket or balloon to completely clear the stones in the targeted area of the pancreatic duct.
post-ERCP complications
Major post-ERCP complications includes post-ERCP pancreatitis, bleeding, infection, and perforation, which are classified as mild, moderate, or severe, depending mainly on the length of hospitalization and the need for invasive treatment.

Full Information

First Posted
March 13, 2022
Last Updated
February 21, 2023
Sponsor
Changhai Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05289362
Brief Title
Comparison of Efficacy of Basket and Balloon in the Removal of Pancreatic Duct Stones in Chronic Pancreatitis Under ERCP
Official Title
Comparison of Efficacy of Basket and Balloon in the Removal of Pancreatic Duct Stones in Chronic Pancreatitis Under ERCP: a Single-blind, Parallel, Randomized Controlled Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
July 15, 2022 (Actual)
Study Completion Date
March 12, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will compare the efficacy of basket and balloon in the removal of pancreatic duct stones under ERCP.
Detailed Description
Chronic pancreatitis (CP) is an inflammatory disease that can causes progressive fibrosis of pancreatic tissue and eventually leads to damage of pancreatic exocrine and endocrine. According to statistics, the prevalence of CP in China is 13/10 million, which is still increasing. Pancreatic duct stones are the most important pathological changes of CP. More than 50% of patients with CP are accompanied by pancreatic duct stones, which can lead to pancreatic duct obstruction, hypertension and tissue ischemia. Removal of pancreatic duct stones under Endoscopic retrograde cholangiopancreatography (ERCP) are the first choice. ERCP is effective in the treatment of pancreatic duct stones (diameter < 5mm) located in the head/body of the pancreas by using basket and/or balloon catheter. In the clinical work of investigators' center, the ERCP treatment of pancreatic duct stones also mainly adopts basket and balloon, but whether to try basket or balloon first is mainly determined by the subjective decision of the on-site endoscopist. More than 70% of patients use the above two tools in one ERCP operation, which aims to achieve better effect, but the order of the two tools is uncertain. However, there is no relevant research on whether the first choice for the treatment of pancreatic duct stones is the basket or the balloon, or the combination of the two tools. This study will compare the efficacy of basket and balloon in the removal of pancreatic duct stones under ERCP, including the difference of stone clearance rate, abdominal pain score (Izbicki Pain Score), postoperative complications and medical expenses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis, Chronic, Pancreatic Duct Stone
Keywords
Cholangiopancreatography, Endoscopic Retrograde

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treating pancreatic duct stones by using baskets
Arm Type
Experimental
Arm Description
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.
Arm Title
Treating pancreatic duct stones by using balloons
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Basket group
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Balloon group
Intervention Description
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.
Primary Outcome Measure Information:
Title
clearance rates of pancreatic duct stones
Description
Clearance rates have been defined as complete, partial, or failure if the proportion of stones cleared was > 90%, 50% - 90%, or < 50%, respectively.
Time Frame
during ERCP procedure
Secondary Outcome Measure Information:
Title
timeout rate
Description
Basket or balloon cannot completely remove stones in the targeted area of the pancreatic duct within 15 minutes.
Time Frame
during ERCP procedure
Title
time taken to completely clear the stone
Description
The time taken by the basket or balloon to completely clear the stones in the targeted area of the pancreatic duct.
Time Frame
during ERCP procedure
Title
number of times to completely clear the stone
Description
The number of attempts made by the basket or balloon to completely clear the stones in the targeted area of the pancreatic duct.
Time Frame
during ERCP procedure
Title
post-ERCP complications
Description
Major post-ERCP complications includes post-ERCP pancreatitis, bleeding, infection, and perforation, which are classified as mild, moderate, or severe, depending mainly on the length of hospitalization and the need for invasive treatment.
Time Frame
30 days after ERCP procedure
Other Pre-specified Outcome Measures:
Title
abdominal pain relief rate
Description
Postoperative and preoperative abdominal pain was assessed using the Visual Analogue Scale (VAS). VAS can be calculated ranging from 0 (no pain) to 100 (severe pain).
Time Frame
30 days after ERCP procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liang-hao Hu, MD
Organizational Affiliation
Changhai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changhai Hospital
City
Shanghai
ZIP/Postal Code
200433
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31238312
Citation
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.
Results Reference
background
PubMed Identifier
24819780
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs