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

NCT05352932 | Unknown DMC

• 1 other identifier: ECHO20220321
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Pancreatitis

Keywords

Endoscopic Retrograde Cholangiopancreatography; Histology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• post-ERCP complications

  30 days after ERCP procedure

Study Arms (1)

patient group

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

Diagnostic Test: pancreatic duct biopsy

Interventions

pancreatic duct biopsy DIAGNOSTIC_TEST

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.

patient group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inpatients meeting the eligibility criteria.

You may qualify if:

• Patients with chronic pancreatitis or idiopathic recurrent acute pancreatitis;
• In line with the indications for ERCP treatment.

You may not qualify if:

• 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.

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

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biopsies will be done under ERCP. During the process, biopsy forceps will be used to take one piece of tissue from the wall of the main pancreatic duct in the head and the body of the pancreas. The maximum diameter of each piece of tissue is not less than 1 mm.

MeSH Terms

Conditions

Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Liang-hao Hu, MD

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 24, 2022
• First Posted: April 29, 2022
• Study Start: March 9, 2022
• Primary Completion: March 10, 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)