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RecruitingNCT06355206NACREUpdated May 9, 2024

Natural Course and Therapeutic Effect of Recurrent Acute Pancreatitis

An observational study in Cohort Study and Recurrent Acute Pancreatitis, sponsored by Changhai Hospital. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2024-05-09.

Sponsored by Changhai Hospital · Observational

From the registry’s dates

  • Started Apr 2024; still recruiting 2 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cohort Study
  • Recurrent Acute Pancreatitis

Keywords

  • recurrent acute pancreatitis
  • natural course
  • therapeutic effect
03

In context

Pancreatitis

752 studies on the registry are indexed under Pancreatitis; 180 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 179 across 276 observational studies indexed under Pancreatitis.

Browse Pancreatitis studies →

Lead sponsor

Changhai Hospital is the lead sponsor of 342 studies on the registry; 133 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients whti recurrent acute pancreatitis come from Changhai Hospital.

Inclusion criteria

  • Patients with recurrent acute pancreatitis.

Exclusion criteria

Exclusion Criteria:

  • Unwilling or unable to provide consent.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • Combination productendoscopic intervention, surgery or conservative treatment

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

06

What researchers measure

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.

    Time frame: Through study completion, an average of 1 year

Secondary outcomes

  1. Proportion of patients with different treatment

    Treatment mainly contains conservative treatment, surgery, endoscopic intervention, etc. Collect relevant data through medical record.

    Time frame: Through study completion, an average of 1 year

  2. Characteristics of acute pancreatitis

    Collect relevant data through medical record. Characteristics of acute pancreatitis includ etiology, frequency, severity and length of hospital.

    Time frame: Through study completion, an average of 1 year

  3. 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.

    Time frame: Through study completion, an average of 3 year

  4. Proportion of patients with chronic pancreatitis

    Proportion of patients who developed chronic pancreatitis.

    Time frame: Through study completion, an average of 3 year

  5. Evaluation of quality of life

    The level of quality of life in RAP patients is measured using the SF-36.

    Time frame: Through study completion, an average of 3 year

  6. Evaluation of psychological condition

    The psychological condition of RAP patients is measured using DASS-21.

    Time frame: Through study completion, an average of 3 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06355206
Lead sponsor
Changhai Hospital
Responsible party
Zhaoshen Li (Professor, Changhai Hospital) — Principal investigator
First posted
Apr 9, 2024
Start date
Apr 22, 2024
Primary completion
Dec 2034 (estimated)
Completion
Dec 2034 (estimated)
Last update
May 9, 2024

Study contacts

Lianghao Hu, M.D.
Contact
lianghao-hu@smmu.edu.cn
+86-13817593520
Xiaoyu Zhou
Contact
xyzhou0116@163.com
+86-17721292061
Zhaoshen Li, M.D.
study chair · Changhai Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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