Comparison of Efficacy of ESWL and Laser Lithotripsy in Chronic Pancreatitis With ERCP

NCT05326542 | Unknown DMC

• 1 other identifier: ECLIPSE20220312
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the efficacy of ESWL and Laser Lithotripsy in the treatment of pancreatic duct stones with ERCP.

Conditions

Pancreatitis, Chronic; Pancreatic Duct Stone

Keywords

Cholangiopancreatography, Endoscopic Retrograde; Lithotripsy

Outcome Measures

Primary Outcomes (2)

• technical success rates

  Technical success rates refer to the successful completion of standard procedures or the occurrence of complete spontaneous stone removal.

  during ERCP procedure

• 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 (3)

• time taken to completely clear the stone

  during ESWL and ERCP procedure

• postoperative complications

  30 days after ERCP procedure

• success rates of pancreatic duct decompression

  during ERCP procedure

Other Outcomes (1)

• abdominal pain relief rate

  30 days after ERCP procedure

Study Arms (2)

ESWL and ERCP

EXPERIMENTAL

The patients will receive intravenous analgesia (flurbiprofen and remifentanil) before the ESWL (Compact Delta II; Dornier Med Tech, Wessling, Germany). The time scale between the last ESWL session and following ERCP will be greater than 48h. 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 will be performed. A dilating bougie or balloon will be used to dilate the stenosis after sphincterotomy. Standard techniques (i.e., extraction basket, extraction balloon, or both) will be used for stone removal. A pancreatic duct stent or a nasopancreatic catheter will be inserted for temporary drainage if necessary.

Procedure: ESWL and ERCP

LL and ERCP

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 will be performed. A dilating bougie or balloon will be used to dilate the stenosis after sphincterotomy. After that, laser lithotripsy will be performed. Standard techniques (i.e., extraction basket, extraction balloon, or both) will be used for stone removal. A pancreatic duct stent or a nasopancreatic catheter will be inserted for temporary drainage if necessary.

Procedure: LL and ERCP

Interventions

ESWL and ERCP PROCEDURE

First, ESWL will be used for lithotripsy, and then ERCP will be performed to clear the stones after lithotripsy.

ESWL and ERCP

LL and ERCP PROCEDURE

After establishing the working channel under ERCP, the stone will be crushed with a laser lithotripter, and then ERCP will clear the stones after lithotripsy.

LL and ERCP

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;
• at least one stone (\>5 mm in diameter) located in the pancreatic duct of the head/body of the pancreas;
• dilation of the proximal pancreatic duct.

You may not qualify if:

• history of ERCP or ESWL treatment;
• suspected to have malignant tumors;
• history of pancreatic surgery or gastrojejunostomy (Billroth II);
• pancreatic pseudocyst with a diameter \>4cm;
• bile duct stricture secondary to cholangitis or chronic pancreatitis;
• acute pancreatitis exacerbation or acute exacerbation of chronic pancreatitis (including biliary pancreatitis);
• 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 (1)

• 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

MeSH Terms

Conditions

Pancreatitis, Chronic

Interventions

Lithotripsy; Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Ultrasonic Surgical Procedures; Surgical Procedures, Operative; Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Minimally Invasive Surgical Procedures

Study Officials

• Liang-hao Hu, MD

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liang-hao Hu, MD

CONTACT

+86-13817593520; ianghao-hu@smmu.edu.cn

Zhao-shen Li, MD

CONTACT

+86-13901960921; zhaoshen-li@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 13, 2022
• Study Start: September 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 14, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)