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

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Brief Title

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

Official Title

ESWL Combined With ERCP and Laser Lithotripsy Combined With ERCP In Treatment of Pancreatic Duct Stones With Chronic Pancreatitis: a Randomized Controlled Trial

Brief Summary

      This study will compare the efficacy of ESWL and Laser Lithotripsy in the treatment of
      pancreatic duct stones with 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 by using basket and/or balloon
      catheter. But in most cases, ERCP is only suitable for the treatment of pancreatic duct
      stones (diameter < 5mm) located in the head/body of the Pancreatic Duct (PD). PD stones
      larger than 5mm generally require Extracorporeal Shock Wave Lithotripsy (ESWL) or Endoscopic
      Intraductal Lithotripsy (EIL) for pretreatment. EIL includes Electrohydraulic Lithotripsy
      (EHL) and Laser Lithotripsy (LL).

      ESWL first locates the stone by X-ray, and then uses an electromagnetic pulse generator to
      direct a higher-energy shock wave to the stone, so that the stone is crushed by thousands of
      shock waves. The principle of laser lithotripsy is to make the stone absorb strong infrared
      rays and generate shock waves to achieve the purpose of fragmenting the stone.

      In view of the fact that there is no relevant research comparing the overall efficacy of ESWL
      combined with ERCP and EIL combined with ERCP, it is necessary to evaluate the differences in
      the therapeutic effects and complications of the two for PD stones. This research helps to
      provide evidence-based medical evidence, guide physicians' clinical practice, improve the
      quality of patients' lives, and reduce the economic burden of patients.
    


Study Type

Interventional


Primary Outcome

technical success rates

Secondary Outcome

 time taken to completely clear the stone

Condition

Pancreatitis, Chronic

Intervention

ESWL and ERCP

Study Arms / Comparison Groups

 ESWL and ERCP
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

80

Start Date

September 2022

Completion Date

December 2022

Primary Completion Date

October 2022

Eligibility Criteria

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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.
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Liang-hao Hu, MD, +86-13817593520, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT05326542

Organization ID

ECLIPSE20220312


Responsible Party

Principal Investigator

Study Sponsor

Changhai Hospital


Study Sponsor

Liang-hao Hu, MD, Principal Investigator, Changhai Hospital


Verification Date

September 2022