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Natural Course and Therapeutic Effect of Recurrent Acute Pancreatitis

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06355206
Acronym
NACRE
Enrollment
2000
Registered
2024-04-09
Start date
2024-04-22
Completion date
2034-12-31
Last updated
2024-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cohort Study, Recurrent Acute Pancreatitis

Keywords

recurrent acute pancreatitis, natural course, therapeutic effect

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.

Detailed 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.

Interventions

COMBINATION_PRODUCTendoscopic intervention, surgery or conservative treatment

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

Sponsors

Changhai Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients with recurrent acute pancreatitis.

Exclusion criteria

* Unwilling or unable to provide consent.

Design outcomes

Primary

MeasureTime frameDescription
Recurrence rate of acute pancreatitisThrough study completion, an average of 1 yearAcute 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.

Secondary

MeasureTime frameDescription
Characteristics of acute pancreatitisThrough study completion, an average of 1 yearCollect relevant data through medical record. Characteristics of acute pancreatitis includ etiology, frequency, severity and length of hospital.
Proportion of patients wtih pain in RAP patientsThrough study completion, an average of 3 yearCollect relevant data through pain assessment scales which include severity, frequency, time of duration and other characteristics of pancreatic pain.
Proportion of patients with different treatmentThrough study completion, an average of 1 yearTreatment mainly contains conservative treatment, surgery, endoscopic intervention, etc. Collect relevant data through medical record.
Evaluation of quality of lifeThrough study completion, an average of 3 yearThe level of quality of life in RAP patients is measured using the SF-36.
Evaluation of psychological conditionThrough study completion, an average of 3 yearThe psychological condition of RAP patients is measured using DASS-21.
Proportion of patients with chronic pancreatitisThrough study completion, an average of 3 yearProportion of patients who developed chronic pancreatitis.

Countries

China

Contacts

Primary ContactLianghao Hu, M.D.
lianghao-hu@smmu.edu.cn+86-13817593520
Backup ContactXiaoyu Zhou
xyzhou0116@163.com+86-17721292061

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026