Cohort StudyNACRENCT06355206
Natural Course and Therapeutic Effect of Recurrent Acute Pancreatitis
An observational study of Cohort Study and Recurrent Acute Pancreatitis, run by Changhai Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cohort Study, Recurrent Acute Pancreatitis
- What is being tested?
- endoscopic intervention, surgery or conservative treatment
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2024to Dec 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients whti recurrent acute pancreatitis come from Changhai Hospital.
Who may be able to join
- Patients with recurrent acute pancreatitis.
Who cannot join
- Unwilling or unable to provide consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Lianghao Hu, M.D., lianghao-hu@hotmail.com
About this study
Official title: Natural Course and Therapeutic Effect of Recurrent Acute Pancreatitis: a Prospective Cohort Study
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.
- Conditions
- Cohort Study, Recurrent Acute Pancreatitis
- Being tested
- endoscopic intervention, surgery or conservative treatment
- Keywords
- recurrent acute pancreatitis, natural course, therapeutic effect
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic intervention, surgery or conservative treatmentCombination product
Personal information and treatment of the enrolled subjects will be collected.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: endoscopic intervention, surgery or conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year
Secondary outcomes (6)
Proportion of patients with different treatment
Treatment mainly contains conservative treatment, surgery, endoscopic intervention, etc. Collect relevant data through medical record.
Measured: Through study completion, an average of 1 year
Characteristics of acute pancreatitis
Collect relevant data through medical record. Characteristics of acute pancreatitis includ etiology, frequency, severity and length of hospital.
Measured: Through study completion, an average of 1 year
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.
Measured: Through study completion, an average of 3 year
Proportion of patients with chronic pancreatitis
Proportion of patients who developed chronic pancreatitis.
Measured: Through study completion, an average of 3 year
Evaluation of quality of life
The level of quality of life in RAP patients is measured using the SF-36.
Measured: Through study completion, an average of 3 year
Evaluation of psychological condition
The psychological condition of RAP patients is measured using DASS-21.
Measured: Through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start22 Apr 2024
- Primary completionDec 2034 (estimated)
- Study completionDec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cohort StudyStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Zhaoshen Li, M.D., Study chair, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355206
- Sponsor's protocol ID
- NACRE20230306
- Acronym
- NACRE
- Status last verified
- May 2024
- First submitted
- 28 Mar 2024
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural Course and Therapeutic Effect of Recurrent Acute Pancreatitis: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06355206
- Acronym / sponsor ID
- NACRE / NACRE20230306
- Conditions
- Cohort Study, Recurrent Acute Pancreatitis
- Keywords
- recurrent acute pancreatitis, natural course, therapeutic effect
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- Dec 2034 (estimated)
- Study completion
- Dec 2034 (estimated)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| recurrent acute pancreatitis | – | Combination Product: endoscopic intervention, surgery or conservative treatmentRecurrent 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients whti recurrent acute pancreatitis come from Changhai Hospital.
Key inclusion criteria (1 listed)
- Patients with recurrent acute pancreatitis.
Key exclusion criteria (1 listed)
- Unwilling or unable to provide consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopic intervention, surgery or conservative treatmentPersonal information and treatment of the enrolled subjects will be collected. | Combination product | recurrent acute pancreatitis |
Primary outcome
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.
6 secondary outcomes
Proportion of patients with different treatment
Time frame: Through study completion, an average of 1 year
Characteristics of acute pancreatitis
Time frame: Through study completion, an average of 1 year
Proportion of patients wtih pain in RAP patients
Time frame: Through study completion, an average of 3 year
Proportion of patients with chronic pancreatitis
Time frame: Through study completion, an average of 3 year
Evaluation of quality of life
Time frame: Through study completion, an average of 3 year
Evaluation of psychological condition
Time frame: Through study completion, an average of 3 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhaoshen Li, M.D. study chair
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cohort Study and Recurrent Acute Pancreatitis, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lianghao Hu, M.D. (+86-13817593520, lianghao-hu@smmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate of acute pancreatitis (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.