Establishment of Clinical Staging of Chronic Pancreatitis Based on Histopathology of Pancreatic Duct Biopsy

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Brief Title

Establishment of Clinical Staging of Chronic Pancreatitis Based on Histopathology of Pancreatic Duct Biopsy

Official Title

Establishment of Clinical Staging of Chronic Pancreatitis Based on Histopathology of Pancreatic Duct Biopsy: a Cross-sectional Clinical Study

Brief Summary

      This study intends to establish the clinical staging of chronic pancreatitis based on
      histopathology through pancreatic duct biopsy technology.
    

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.

      Pathological features of CP include pancreatic parenchymal atrophy and interstitial fibrosis
      resulting from chronic inflammatory damage. Although there are numerous criteria for clinical
      staging and severity grading of CP, they all have their own limitations, and none of them
      have been validated by randomized controlled trials. There is also no clear definition of the
      clinical stage and severity of CP in the guidelines for the diagnosis and treatment of CP.
      According to the "Clinical Guideline: Chronic Pancreatitis" issued by the American College of
      Gastroenterology in 2020, histopathology is the "gold standard" for the diagnosis of CP.

      In the past ten years, the technology of mother-daughter scope has developed rapidly. The
      duodenoscope is used as the mother scope, and the cholangiopancreatoscope is used as the
      daughter scope. The optical fiber or digital imaging system carried by the daughter scope can
      directly observe the internal situation of the pancreatic and bile ducts. The channel allows
      the endoscopist to precisely biopsy the wall of the main pancreatic duct with a biopsy
      forceps. This technology improves the predicament of pancreatic tissue biopsy in the past,
      allowing ERCP treatment in patients with CP and pancreatic tissue biopsy to be carried out
      simultaneously.
    


Study Type

Observational


Primary Outcome

Histopathological scoring of pancreatic duct biopsy specimens

Secondary Outcome

 post-ERCP complications

Condition

Chronic Pancreatitis

Intervention

pancreatic duct biopsy

Study Arms / Comparison Groups

 patient group
Description:  Patients with chronic pancreatitis or idiopathic recurrent acute pancreatitis are considered as study subjects.

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

Diagnostic Test

Estimated Enrollment

120

Start Date

March 9, 2022

Completion Date

December 2022

Primary Completion Date

March 10, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with chronic pancreatitis or idiopathic recurrent acute pancreatitis;

          -  In line with the indications for ERCP treatment.

        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;

          -  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, , 

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT05352932

Organization ID

ECHO20220321


Responsible Party

Principal Investigator

Study Sponsor

Changhai Hospital


Study Sponsor

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


Verification Date

September 2022