Natural Course and Therapeutic Effect of Recurrent Acute Pancreatitis

NCT06355206 | Recruiting DMC

• 1 other identifier: NACRE20230306
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational cohort study is to learn about the etiology, natural course, therapeutic effect and outcome of recurrent acute pancreatitis patients. The main question it aims to answer is: Does endoscopic intervention, surgery or conservative treatment reduce the recurrence of acute pancreatitis? What are the risk factors affecting the recurrence of acute pancreatitis? Patients will be closely followed and clinical information will be recorded.

Conditions

Cohort Study; Recurrent Acute Pancreatitis

Keywords

recurrent acute pancreatitis; natural course; therapeutic effect

Outcome Measures

Primary Outcomes (1)

• Recurrence rate of acute pancreatitis

  Acute pancreatitis is diagnosed according to the revised Atlanta classification, which requires 2 of the 3 following criteria: (1) abdominal pain suggestive of pancreatitis, (2) serum amylase and/or lipase greater than 3 times the upper limit of normal, (3) and crosssectional imaging (CT or MRI) findings consistent with acute pancreatitis.

  Through study completion, an average of 1 year

Secondary Outcomes (6)

• Proportion of patients with different treatment

  Through study completion, an average of 1 year

• Characteristics of acute pancreatitis

  Through study completion, an average of 1 year

• Proportion of patients wtih pain in RAP patients

  Through study completion, an average of 3 year

• Proportion of patients with chronic pancreatitis

  Through study completion, an average of 3 year

• Evaluation of quality of life

  Through study completion, an average of 3 year

Study Arms (1)

recurrent acute pancreatitis

Recurrent acute pancreatitis is generally defined as a condition in which at least two well documented episodes of acute pancreatitis have occurred, with resolution of symptoms between each episode, and absence of morphological criteria for chronic pancreatitis.

Combination Product: endoscopic intervention, surgery or conservative treatment

Interventions

endoscopic intervention, surgery or conservative treatment COMBINATION_PRODUCT

Personal information and treatment of the enrolled subjects will be collected.

recurrent acute pancreatitis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients whti recurrent acute pancreatitis come from Changhai Hospital.

You may qualify if:

• Patients with recurrent acute pancreatitis.

You may not qualify if:

• Unwilling or unable to provide consent.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Feces and blood samples from RAP patients will be collected.

MeSH Terms

Conditions

Pancreatitis

Interventions

Surgical Procedures, Operative; Conservative Treatment

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Zhaoshen Li, M.D.

  Changhai Hospital

  STUDY CHAIR

Central Study Contacts

Lianghao Hu, M.D.

CONTACT

+86-13817593520; lianghao-hu@smmu.edu.cn

Xiaoyu Zhou

CONTACT

+86-17721292061; xyzhou0116@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 9, 2024
• Study Start: April 22, 2024
• Primary Completion (Estimated): December 1, 2034
• Study Completion (Estimated): December 1, 2034
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)