Endotherapy for Painless Chronic Pancreatitis

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Brief Title

Endotherapy for Painless Chronic Pancreatitis

Official Title

Effect of Endotherapy on the Progression of Chronic Pancreatitis in Painless Patients

Brief Summary

      This is a prospective randomized controlled trial. . Patients will be divided into
      conservative or endoscopic group and fecal pancreatic elastase-1 (FE-1) is tested to evaluate
      pancreatic exocrine function. The effect of extracorporeal shock wave lithotripsy and
      endoscopic treatment on the progression of chronic pancreatitis in painless patients will be
      determined.
    

Detailed Description

      This is a prospective, randomized controlled trial. Patients will be divided into
      conservative or endoscopic group and FE-1 is tested to evaluate pancreatic exocrine function.
      The effect of extracorporeal shock wave lithotripsy and endoscopic treatment on the
      progression of chronic pancreatitis in painless patients will be determined.

      Chronic pancreatitis (CP) is a pathologic fibro-inflammatory syndrome of the pancreas that
      eventually leads to damage of the gland in individuals with genetic, environmental and/or
      other risk factors. If widespread, this damage causes failure of exocrine and endocrine
      pancreatic function resulting in steatorrhea and diabetes. The global pooled incidence of CP
      is 10 cases [95% Confidence interval (CI) 8-12] per 100,000 general population per year.
      Endoscopic retrograde cholangiopancreatography (ERCP) and extracorporeal shock wave
      lithotripsy (ESWL) has become first-line therapy for patients with chronic pancreatitis
      according to guidelines. Endoscopic therapy has been proved effective and safe. The clearance
      rate of pancreatic stones was 42-76%, and the pain relief rate was 15-85%.

      Pain is the major clinical features of CP and remained a major clinical challenge. It is
      present in up to 90% of patients and is the main cause of hospitalization in most
      patients.Patten of pain for patients with chronic pancreatitis differs widely.

      However, some CP patients have never had abdominal pain during the course of the disease, and
      participants are often diagnosed with CP due to diabetes or steatorrhea, which are called
      painless CP, accounting for about 10% of the CP population. These patients are mainly
      characterized as pancreatic endocrine and exocrine insufficiency. Some studies proposed that
      painless CP may be related to the severity of inflammation and the pain sensitivity of
      patients, but the mechanism has not yet been elucidated.

      It is still controversial whether painless CP requires active endoscopic intervention or not.
      The United European Gastroenterology evidence-based guidelines does not recommend endoscopic
      treatment in painless CP patients, but the recommendation is not supported by strong clinical
      research evidence. European Society of Gastrointestinal Endoscopy (ESGE) Guideline proposed
      whether active endoscopic treatment had a protective effect on the pancreatic function of
      patients with painless CP is still unconfirmed. On the contrary, a small sample study
      consisting of 41 CP patients by Katsushi found that endoscopic treatment can delay the
      progression of exocrine dysfunction in CP patients.Considering these contradicting results,
      it is urgent to conduct a clinical study to determine the effect of endoscopic treatment on
      preservation of pancreatic function in patients with CP.

      Therefore, this study intends to use clinical prospective trials to explore whether patients
      with painless CP can benefit from active endoscopic minimally invasive interventions
      (including ERCP, ESWL, etc.), including slowing down the deterioration of pancreatic
      endocrine and exocrine function and improving patients' life quality and other aspects, and
      then provide an important reference basis for the clinical treatment of this type of
      patients.

      Considering all these backgrounds, the primary outcome aimed to explore whether painless CP
      patients can benefit from endoscopic interventions (including ERCP, ESWL, etc.), including
      slowing down the deterioration of pancreatic endocrine and exocrine function, improving
      patients' life quality and other aspects. Based on the above, this study intends to provide
      important reference for the clinical treatment of painless CP patients.
    


Study Type

Interventional


Primary Outcome

exocrine function of the pancreas assessed by the value of fecal elastase in μg/g

Secondary Outcome

 endocrine function of the pancreas assessed by glycosylated hemoglobin in %.

Condition

Pancreatitis, Chronic

Intervention

extracorporeal shock wave lithotripsy and endoscopic drainage of the main pancreatic duct

Study Arms / Comparison Groups

 Endoscopic group
Description:  The patients received intravenous analgesia (flurbiprofen and remifentanil) before the ESWL (Compact Delta II; Dornier Med Tech, Wessling, Germany). After the last ESWL session, the patients are treated with following ERCP within 48h. ERCP was performed under conscious sedation with intramuscular administration of diazepam 2.5-5.0 mg and pethidine 25-50 mg. If necessary, endoscopic sphincterotomy was 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 for drainage and nasopancreatic catheters will be inserted for temporary drainage if necessary. Conservative treatments similar to patients in the control group were given in endoscopic group according to patients' condition.

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

60

Start Date

March 2022

Completion Date

November 2023

Primary Completion Date

November 2023

Eligibility Criteria

        Inclusion Criteria:

          -  diagnosed with chronic pancreatitis without pain attack related with chronic
             pancreatitis;

          -  calcified stone in the cephalic or corporeal portion of the main pancreatic duct with
             upstream duct dilation;

          -  no ERCP or ESWL carried out before admission;

        Exclusion Criteria:

          -  suspected to have malignant tumors;

          -  history of pancreatic surgery or gastrojejunostomy (Billroth II);

          -  with end-stage disease;

          -  pregnancy or lactation;

          -  refuse to write informed consent
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Zhuan Liao, MD, 13061921980, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT05261997

Organization ID

Painless CP


Responsible Party

Principal Investigator

Study Sponsor

Changhai Hospital


Study Sponsor

Zhuan Liao, MD, Principal Investigator, Shanghai Changhai Hospital, Shanghai, China


Verification Date

February 2022