Post-ERCP Acute PancreatitisNCT02781987
Incidence and Risk Factor of Post-ERCP Pancreatitis in Chronic Pancreatitis
An observational study of Post-ERCP Acute Pancreatitis, run by Changhai Hospital.
Trial summary
The purpose of this study is to compare the incidence of post-ERCP pancreatitis (PEP) in chronic pancreatitis (CP) patients to that in biliary disease patients, to determine whether CP patients in early clinical stage have a higher PEP incidence, and to identify the predictive and protective factors for PEP in chronic… Read more about this study
- Who is it for?
- Ages 5 to 85 years
- Conditions the study is for
- Post-ERCP Acute Pancreatitis
- What is being tested?
- chronic pancreatitis
- How many people
- 2,028 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 5 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Chronic pancreatitis patients underwent ERCP from January 2011 to May 2015 in Changhai Hospital.
Who may be able to join
- patients with an endoscope inserted to cannulate the pancreatic/biliary duct were included.
Who cannot join
- patients in whom the papilla of Vater was not reached;
- patients who underwent stent removal procedures without ductal cannulation;
- patients in whom the intubation was failed.
About this study
Official title: Changhai Hospital, the Second Military Medical University
The purpose of this study is to compare the incidence of post-ERCP pancreatitis (PEP) in chronic pancreatitis (CP) patients to that in biliary disease patients, to determine whether CP patients in early clinical stage have a higher PEP incidence, and to identify the predictive and protective factors for PEP in chronic pancreatitis patients.
Read the detailed description
Analysis of patients with chronic pancreatitis (CP group) and biliary disease (BD group) in Changhai Hospital from January 2011 to May 2015 were conducted. Difference of PEP incidences between BD group and CP group, as well as between M-ANNHEIM subcategories were calculated by chi-square test or Fisher's exact test. The predictive and protective factors for PEP were investigated by univariate and multivariate analysis.
- Conditions
- Post-ERCP Acute Pancreatitis
- Being tested
- chronic pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chronic pancreatitisOther
patients with chronic pancreatitis
| Study group | Role | What they receive |
|---|---|---|
| CP group | Those patients with chronic pancreatitis underwent ERCP for pancreatic stone clearance, pancreatic stent placement, etc.. Receives: Other: chronic pancreatitis | |
| BD group | Those patients with biliary ductal disease, such as choledocholithiasis, underwent ERCP to relieve outflow obstruction of the common bile duct. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of chronic pancreatitis patients with post-ERCP pancreatitis, diabetes mellitus, steatorrhea, previous pancreatitis, previous PEP, pancreatic divisum, jaundice, ESWL, pancreatic duct stone, drainage and minor papilla pancreatogram.
Measured: 8 months
Secondary outcomes (1)
Numbers of biliary disease patients with post-ERCP pancreatitis, previous pancreatitis and previous PEP.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study startJan 2011
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-ERCP Acute PancreatitisStudies 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
- Case-control
- Enrolment
- 2,028 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhuan Liao, Changhai Hospital
- Investigators
- Zhao-shen Li, Study chair, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02781987
- Sponsor's protocol ID
- PEP-CP
- Other IDs
- 81470884, 81422010, 81270541, 13QA1404600
- Status last verified
- Jan 2017
- First submitted
- 18 May 2016
- Last updated
- 13 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Zhao ZH, Hu LH, Ren HB, Zhao AJ, Qian YY, Sun XT, Su S, Zhu SG, Yu J, Zou WB, Guo XR, Wang L, Li ZS, Liao Z. Incidence and risk factors for post-ERCP pancreatitis in chronic pancreatitis. Gastrointest Endosc. 2017 Sep;86(3):519-524.e1. doi: 10.1016/j.gie.2016.12.020. Epub 2017 Jan 4.
PubMed 28062312
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changhai Hospital, the Second Military Medical University
- ClinicalTrials.gov ID
- NCT02781987
- Acronym / sponsor ID
- PEP-CP
- Conditions
- Post-ERCP Acute Pancreatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,028 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 25 May 2016 (estimated)
- 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 purpose of this study is to compare the incidence of post-ERCP pancreatitis (PEP) in chronic pancreatitis (CP) patients to that in biliary disease patients, to determine whether CP patients in early clinical stage have a higher PEP incidence, and to identify the predictive and protective factors for PEP in chronic pancreatitis patients.
Detailed description
Analysis of patients with chronic pancreatitis (CP group) and biliary disease (BD group) in Changhai Hospital from January 2011 to May 2015 were conducted. Difference of PEP incidences between BD group and CP group, as well as between M-ANNHEIM subcategories were calculated by chi-square test or Fisher's exact test. The predictive and protective factors for PEP were investigated by univariate and multivariate analysis.
Study design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CP group | – | Other: chronic pancreatitisThose patients with chronic pancreatitis underwent ERCP for pancreatic stone clearance, pancreatic stent placement, etc.. |
| BD group | – | –Those patients with biliary ductal disease, such as choledocholithiasis, underwent ERCP to relieve outflow obstruction of the common bile duct. |
Who may qualify
- Ages
- 5 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Chronic pancreatitis patients underwent ERCP from January 2011 to May 2015 in Changhai Hospital.
Key inclusion criteria (1 listed)
- patients with an endoscope inserted to cannulate the pancreatic/biliary duct were included.
Key exclusion criteria (3 listed)
- patients in whom the papilla of Vater was not reached;
- patients who underwent stent removal procedures without ductal cannulation;
- patients in whom the intubation was failed.
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 |
|---|---|---|
| chronic pancreatitispatients with chronic pancreatitis | Other | CP group |
Primary outcome
Numbers of chronic pancreatitis patients with post-ERCP pancreatitis, diabetes mellitus, steatorrhea, previous pancreatitis, previous PEP, pancreatic divisum, jaundice, ESWL, pancreatic duct stone, drainage and minor papilla pancreatogram.
Time frame: 8 months
1 secondary outcome
Numbers of biliary disease patients with post-ERCP pancreatitis, previous pancreatitis and previous PEP.
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2017.
- Results publication: PubMed 28062312Zhao ZH, Hu LH, Ren HB, Zhao AJ, Qian YY, Sun XT, Su S, Zhu SG, Yu J, Zou WB, Guo XR, Wang L, Li ZS, Liao Z. Incidence and risk factors for post-ERCP pancreatitis in chronic pancreatitis. Gastrointest Endosc. 2017 Sep;86(3):519-524.e1. doi: 10.1016/j.gie.2016.12.020. Epub 2017 Jan 4.
- 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. This study is not recruiting at the moment.
Zhao-shen Li study chair
Changhai Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Post-ERCP Acute Pancreatitis, run by Changhai Hospital.
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 3 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: finished, as of the sponsor's last update on 13 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers of chronic pancreatitis patients with post-ERCP pancreatitis, diabetes mellitus, steatorrhea, previous pancreatitis, previous PEP, pancreatic divisum, jaundice, ESWL, pancreatic duct stone, drainage and minor papilla pancreatogram. (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02781987, which also lists 1 linked publication.
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 13 Jan 2017.