Changhai Hospital
Shanghai, Shanghai Municipality, 200433, China
Location status: Recruiting
Recruiting
NCT Number: NCT06355206
Natural Course and Therapeutic Effect of Recurrent Acute Pancreatitis
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients with recurrent acute pancreatitis.
Exclusion criteria
- Unwilling or unable to provide consent.
Treatment and study plan
endoscopic intervention, surgery or conservative treatment
Combination ProductPersonal information and treatment of the enrolled subjects will be collected.
Primary outcomes
-
Recurrence rate of acute pancreatitis
Time frame: Through study completion, an average of 1 year
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.
Secondary outcomes
-
Proportion of patients with different treatment
Time frame: Through study completion, an average of 1 year
Treatment mainly contains conservative treatment, surgery, endoscopic intervention, etc. Collect relevant data through medical record.
-
Characteristics of acute pancreatitis
Time frame: Through study completion, an average of 1 year
Collect relevant data through medical record. Characteristics of acute pancreatitis includ etiology, frequency, severity and length of hospital.
-
Proportion of patients wtih pain in RAP patients
Time frame: Through study completion, an average of 3 year
Collect relevant data through pain assessment scales which include severity, frequency, time of duration and other characteristics of pancreatic pain.
-
Proportion of patients with chronic pancreatitis
Time frame: Through study completion, an average of 3 year
Proportion of patients who developed chronic pancreatitis.
-
Evaluation of quality of life
Time frame: Through study completion, an average of 3 year
The level of quality of life in RAP patients is measured using the SF-36.
-
Evaluation of psychological condition
Time frame: Through study completion, an average of 3 year
The psychological condition of RAP patients is measured using DASS-21.
Study contacts
Contact information is provided by the study sponsor or research team.
Lianghao Hu, M.D.
CONTACT
Xiaoyu Zhou
CONTACT
Sponsors and collaborators
Lead sponsor
Changhai Hospital
Other
Registry information
Official study title
Natural Course and Therapeutic Effect of Recurrent Acute Pancreatitis: a Prospective Cohort Study
Acronym: NACRE
Important dates
- Study start
- 2024
- Primary completion
- 2034
- Study completion
- 2034
- First posted
- Apr 9, 2024
- Registry last updated
- May 9, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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