Acute PancreatitisNCT02928718
The Association Between Post-ERCP Acute Pancreatitis and Various Genetic Mutations
An observational study of Acute Pancreatitis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Pancreatitis remains the most common complication of ERCP, with the reported incidence ranging from 2% to 9%. Although 80% of cases are mild, a significant number of patients may develop severe pancreatitis, that means additional morbidity and risk for death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- ERCP
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 75 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Sep 2016to Jul 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are at high risk of post-ERCP pancreatitis, who have at least one of the following factors: clinically suspected sphincter of Oddi dysfunction, history of post-ERCP pancreatitis, pancreatic sphincterotomy, precut sphincterotomy, difficult cannulation, balloon dilatation of intact sphincter, endoscopic ampullectomy, and 2≥minor criteria(an age of less than 50 years and female sex, a history of recurrent pancreatitis (≥2 episodes), three or more injections of contrast agent into the pancreatic duct with at least one injection to the tail of the pancreas, excessive injection of contrast agent into the pancreatic duct resulting in opacification of pancreatic acini,the acquisition of a cytologic specimen from the pancreatic duct with the use of a brush).
Who may be able to join
- Patients who undergo ERCP with high risk factors of post-ERCP pancreatitis
Who cannot join
- <18 years old
- current pancreatitis (<72hrs before ERCP)
- pregnant woman, breast-feeding woman
- patient refusal
- contraindication of ERCP
- patients who would only be treated of bile duct such as a change of stent with previous endoscopic sphincterotomy
Show all 9Show fewer
- chronic pancreatitis
- patients who underwent gastrectomy (Billroth II or Roux-en Y anastomosis)
- patients who have pancreatic or distal bile duct cancer
Trial locations and contacts
1 site in 1 country.
About this study
Pancreatitis remains the most common complication of ERCP, with the reported incidence ranging from 2% to 9%. Although 80% of cases are mild, a significant number of patients may develop severe pancreatitis, that means additional morbidity and risk for death. ERCP, despite the development of new diagnostic tools, remains a widely used procedure, so post-ERCP pancreatitis is a problem with significant impact. Several studies and meta-analyses helped us to recognize special factors that put an individual in high risk for the development of post-ERCP pancreatitis. Among these factors special interest presents the history of post-ERCP pancreatitis as an independent risk factor for a new episode of post-ERCP pancreatitis. It seems that some individuals have a genetically predisposed susceptibility in this particular complication. The aim of the present study is to investigate the possible genetic variation associated with post-ERCP pancreatitis using whole genome sequencing.
Read the detailed description
This study includes patients who are at high risk of post-ERCP pancreatitis. Blood samples will be gathered to investigate the possible genetic variation associated with post-ERCP pancreatitis using whole genome sequencing. DNA for whole genome sequencing will be extracted using DNA extraction kit (Qiagen Inc., Hinden, Germany) and the concentration \& purity of DNA will be measured using Nanodrop (Nano Drop Technologies, Wilmington, DE, USA) or fluorometric quantitation(Qubit fluorometer). Genetic variations which are associated with acute pancreatitis will be searched using whole genome sequencing. Post-ERCP pancreatitis is the primary outcome. Medical records and data of genetic variations will be reviewed for identifying possible risk factors and genetic variations associated with post-ERCP pancreatitis.
- Conditions
- Acute Pancreatitis
- Being tested
- ERCP
- Keywords
- Post-ERCP pancreatitis, Genetic variation
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCPProcedure or surgery
Two expert endoscopists will perform ERCP. Patients will be sedated with midazolam(2-5mg) and pethidine(25-50mg) with careful monitoring. Duodenoscope (TJF-240 or TJF-260; Olympus Corp., Tokyo, Japan) will be used. Cholangiography or pancreatography will be gathered after selective bile duct or pancreatic duct cannulation. Therapy such as endoscopic sphincterotomy, stent insertion, and etc., will be done.
| Study group | Role | What they receive |
|---|---|---|
| High risk patients | Patients who are at high risk of post-ERCP pancreatitis, who have at least one of the following factors: clinically suspected sphincter of Oddi dysfunction, history of post-ERCP pancreatitis, pancreatic sphincterotomy, precut sphincterotomy, difficult cannulation, balloon dilatation of intact sphincter, endoscopic ampullectomy, and 2≥minor criteria(an age of less than 50 years and female sex, a history of recurrent pancreatitis (≥2 episodes), three or more injections of contrast agent into the pancreatic duct with at least one injection to the tail of the pancreas, excessive injection of contrast agent into the pancreatic duct resulting in opacification of pancreatic acini,the acquisition of a cytologic specimen from the pancreatic duct with the use of a brush). Receives: Procedure: ERCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-ERCP pancreatitis
Clinical pancreatitis, amylase at least 3 x normal >24h after ERCP
Measured: 24 hours after ERCP
Secondary outcomes (4)
Severe post-ERCP pancreatitis
Pancreatitis requiring hospitalization >10 days, intervention(percutaneous drainage or surgery), development of necrosis, or pseudocyst
Measured: 24 hours after ERCP
hyperamylasemia without symptom
amylase at least 3 x normal > 24h after ERCP, no abdominal pain
Measured: 24 hours after ERCP
Length of stay
Duration of hospitalization
Measured: 3mo
Mortality
mortality
Measured: 3mo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study start29 Sep 2016
- Primary completionJan 2019
- Study completionJul 2019
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 Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Hyub Lee, Seoul National University Hospital
- Investigators
- Sang Hyub Lee, MD. PhD., Principal investigator, Department of internal medicine and liver research institute, Seoul national university hospital, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928718
- Sponsor's protocol ID
- 2015-1992
- Status last verified
- Nov 2022
- First submitted
- 21 Jul 2016
- Last updated
- 18 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Choi YH, Lim Y, Jang DK, Ahn DW, Ryu JK, Paik WH, Kim YT, Kim JH, Lee SH. Genetic susceptibility to post-endoscopic retrograde cholangiopancreatography pancreatitis identified in propensity score-matched analysis. Korean J Intern Med. 2023 Nov;38(6):854-864. doi: 10.3904/kjim.2022.404. Epub 2023 Oct 23.
PubMed 37867141
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Post-ERCP Acute Pancreatitis and Various Genetic Mutations
- ClinicalTrials.gov ID
- NCT02928718
- Acronym / sponsor ID
- 2015-1992
- Conditions
- Acute Pancreatitis
- Keywords
- Post-ERCP pancreatitis, Genetic variation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 29 Sep 2016 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 10 Oct 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.
Pancreatitis remains the most common complication of ERCP, with the reported incidence ranging from 2% to 9%. Although 80% of cases are mild, a significant number of patients may develop severe pancreatitis, that means additional morbidity and risk for death. ERCP, despite the development of new diagnostic tools, remains a widely used procedure, so post-ERCP pancreatitis is a problem with significant impact. Several studies and meta-analyses helped us to recognize special factors that put an individual in high risk for the development of post-ERCP pancreatitis. Among these factors special interest presents the history of post-ERCP pancreatitis as an independent risk factor for a new episode of post-ERCP pancreatitis. It seems that some individuals have a genetically predisposed susceptibility in this particular complication. The aim of the present study is to investigate the possible genetic variation associated with post-ERCP pancreatitis using whole genome sequencing.
Detailed description
This study includes patients who are at high risk of post-ERCP pancreatitis. Blood samples will be gathered to investigate the possible genetic variation associated with post-ERCP pancreatitis using whole genome sequencing. DNA for whole genome sequencing will be extracted using DNA extraction kit (Qiagen Inc., Hinden, Germany) and the concentration \& purity of DNA will be measured using Nanodrop (Nano Drop Technologies, Wilmington, DE, USA) or fluorometric quantitation(Qubit fluorometer). Genetic variations which are associated with acute pancreatitis will be searched using whole genome sequencing. Post-ERCP pancreatitis is the primary outcome. Medical records and data of genetic variations will be reviewed for identifying possible risk factors and genetic variations associated with post-ERCP pancreatitis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High risk patients | – | Procedure: ERCPPatients who are at high risk of post-ERCP pancreatitis, who have at least one of the following factors: clinically suspected sphincter of Oddi dysfunction, history of post-ERCP pancreatitis, pancreatic sphincterotomy, precut sphincterotomy, difficult cannulation, balloon dilatation of intact sphincter, endoscopic ampullectomy, and 2≥minor criteria(an age of less than 50 years and female sex, a history of recurrent pancreatitis (≥2 episodes), three or more injections of contrast agent into the pancreatic duct with at least one injection to the tail of the pancreas, excessive injection of contrast agent into the pancreatic duct resulting in opacification of pancreatic acini,the acquisition of a cytologic specimen from the pancreatic duct with the use of a brush). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are at high risk of post-ERCP pancreatitis, who have at least one of the following factors: clinically suspected sphincter of Oddi dysfunction, history of post-ERCP pancreatitis, pancreatic sphincterotomy, precut sphincterotomy, difficult cannulation, balloon dilatation of intact sphincter, endoscopic ampullectomy, and 2≥minor criteria(an age of less than 50 years and female sex, a history of recurrent pancreatitis (≥2 episodes), three or more injections of contrast agent into the pancreatic duct with at least one injection to the tail of the pancreas, excessive injection of contrast agent into the pancreatic duct resulting in opacification of pancreatic acini,the acquisition of a cytologic specimen from the pancreatic duct with the use of a brush).
Key inclusion criteria (1 listed)
- Patients who undergo ERCP with high risk factors of post-ERCP pancreatitis
Key exclusion criteria (9 listed)
- <18 years old
- current pancreatitis (<72hrs before ERCP)
- pregnant woman, breast-feeding woman
- patient refusal
- contraindication of ERCP
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 |
|---|---|---|
| ERCPTwo expert endoscopists will perform ERCP. Patients will be sedated with midazolam(2-5mg) and pethidine(25-50mg) with careful monitoring. Duodenoscope (TJF-240 or TJF-260; Olympus Corp., Tokyo, Japan) will be used. Cholangiography or pancreatography will be gathered after selective bile duct or pancreatic duct cannulation. Therapy such as endoscopic sphincterotomy, stent insertion, and etc., will be done. | Procedure or surgery | High risk patients |
Primary outcome
Post-ERCP pancreatitis
Time frame: 24 hours after ERCP
Clinical pancreatitis, amylase at least 3 x normal >24h after ERCP
4 secondary outcomes
Severe post-ERCP pancreatitis
Time frame: 24 hours after ERCP
hyperamylasemia without symptom
Time frame: 24 hours after ERCP
Length of stay
Time frame: 3mo
Mortality
Time frame: 3mo
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 18 Nov 2022.
- Derived from this study: PubMed 37867141Choi YH, Lim Y, Jang DK, Ahn DW, Ryu JK, Paik WH, Kim YT, Kim JH, Lee SH. Genetic susceptibility to post-endoscopic retrograde cholangiopancreatography pancreatitis identified in propensity score-matched analysis. Korean J Intern Med. 2023 Nov;38(6):854-864. doi: 10.3904/kjim.2022.404. Epub 2023 Oct 23.
- Individual participant dataSharing planned: Undecided
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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.
Sang Hyub Lee, MD. PhD. principal investigator
Department of internal medicine and liver research institute, Seoul national university hospital, Seoul, Korea
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 Acute Pancreatitis, run by Seoul National University Hospital at 1 site in South Korea.
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 9 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 18 Nov 2022. 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 South Korea. 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?
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?
Post-ERCP pancreatitis (time frame: 24 hours after ERCP). 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 NCT02928718, 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 18 Nov 2022.