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

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Chronic Pancreatitis
• Intervention / Treatment: Diagnostic test: pancreatic duct biopsy

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
• Enrollment (Anticipated): 120

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200433
    • Changhai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Inpatients meeting the eligibility criteria.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Diagnostic test: pancreatic duct biopsy; Enrolled patients will undergo a baseline assessment, including CP history, clinical symptoms, imaging tests, laboratory tests, etc. Then, according to the clinical standard of diagnosis and treatment of chronic pancreatitis, ERCP (with or without Extracorporeal Shock Wave Lithotripsy (ESWL) / endoscopic lithotripsy) will be performed for patients with calculi; pancreatic stent or nasopancreatic stent will be placed for patients with pancreatic duct stenosis. During ERCP, the patient's pancreatic tissue will be biopsied and sent for pathological examination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histopathological scoring of pancreatic duct biopsy specimens	Histopathological evaluations of pancreatic duct biopsies include the presence of ductal squamous metaplasia, the presence of ductal intestinal metaplasia, the presence of ductal dysplasia, the presence of acinar parenchyma, the presence of lobular ducts, the degree of inflammatory cell infiltration (lymphocytes, plasma cells and mast cells) ) and the degree of interstitial fibrosis.	14 days after ERCP procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days after ERCP procedure

Collaborators and Investigators

• Sponsor: Changhai Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2022
• Primary Completion (Actual): March 10, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: April 24, 2022
• First Submitted That Met QC Criteria: April 25, 2022
• First Posted (Actual): April 29, 2022

Study Record Updates

• Last Update Posted (Actual): September 14, 2022
• Last Update Submitted That Met QC Criteria: September 13, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Histology; Endoscopic Retrograde Cholangiopancreatography
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Pancreatitis, Chronic
• Other Study ID Numbers: ECHO20220321

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No