Natural Course and Therapeutic Effect of Recurrent Acute Pancreatitis

Cohort Study Clinical Trial

— NACRE  

Official title:

Natural Course and Therapeutic Effect of Recurrent Acute Pancreatitis: a Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06355206
• Other study ID #: NACRE20230306
• Status: Recruiting
• Start date: April 22, 2024
• Est. completion date: December 2034

Study information

• Verified date: May 2024
• Source: Changhai Hospital
• Contact: Lianghao Hu, M.D.
• Phone: +86-13817593520
• Email: lianghao-hu[@]smmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Acute pancreatitis is one of the most common causes of acute hospital admission, which is unpredictable and contributes to high health-care costs even death. Recurrent acute pancreatitis is defined as two or more discrete episodes of acute pancreatitis, and has an estimated annual incidence of 8-10 per 100 000. Cholelithiasis, alcohol and Hyperglyceremia are the most commonly recognized causes of acute pancreatitis. About 80% of RAP patients can be identified through routine investigations identify (include proper history, physical examination, CT, MRI, endoscopic ultrasound); however, in up to 20% of cases whose cause remains unclear are known as idiopathic RAP. For RAP patients with clear cause, removal of the cause can effectively reduce or prevent recurrence. For patients with idiopathic RAP, the treatment options are not clear and have been subject to debate. At present, the natural course, outcome and therapeutic effect of RAP is still not clear. Therefore, the prospective cohort can clarify the clinical characteristics of RAP more comprehensively and deeply and to accumulate evidence for treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 2034
• Est. primary completion date: December 2034
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with recurrent acute pancreatitis.

Exclusion Criteria:

• Unwilling or unable to provide consent.

Related Conditions & MeSH terms

• Cohort Study
• Pancreatitis
• Recurrence
• Recurrent Acute Pancreatitis

Intervention

Combination Product:
• endoscopic intervention, surgery or conservative treatment
Personal information and treatment of the enrolled subjects will be collected.

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of patients with different treatment	Treatment mainly contains conservative treatment, surgery, endoscopic intervention, etc. Collect relevant data through medical record.	Through study completion, an average of 1 year
Secondary	Characteristics of acute pancreatitis	Collect relevant data through medical record. Characteristics of acute pancreatitis includ etiology, frequency, severity and length of hospital.	Through study completion, an average of 1 year
Secondary	Proportion of patients wtih pain in RAP patients	Collect relevant data through pain assessment scales which include severity, frequency, time of duration and other characteristics of pancreatic pain.	Through study completion, an average of 3 year
Secondary	Proportion of patients with chronic pancreatitis	Proportion of patients who developed chronic pancreatitis.	Through study completion, an average of 3 year
Secondary	Evaluation of quality of life	The level of quality of life in RAP patients is measured using the SF-36.	Through study completion, an average of 3 year
Secondary	Evaluation of psychological condition	The psychological condition of RAP patients is measured using DASS-21.	Through study completion, an average of 3 year