Post-ERCP PancreatitisNCT04750044
Refeeding in Post-ERCP Pancreatitis
A study testing early refeeding and delayed refeeding in people with Post-ERCP Pancreatitis, run by Yonsei University at 9 sites in South Korea.
Trial summary
Endoscopic retrograde cholangio-pancreatography (ERCP) is the most commonly used technique for diagnosis and treatment in the treatment of bile duct diseases including bile duct cholelithiasis and malignant/benign biliary obstruction. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Post-ERCP Pancreatitis
- What is being tested?
- early refeeding and delayed refeeding
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 9 sitesSouth Korea
- Study dates
- 18 Feb 2021to 30 Dec 2022
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 20 to 80
- As patients who developed pancreatitis after receiving ERCP, the following must be satisfied at the same time.
- increased serum amylase or lipase 3 times higher than the normal range, at 4 hours after ERCP or the morning of the following day,
- New or worsening abdominal pain compatible with pancreatitis, arising 4 hours after ERCP or the next morning
Who cannot join
- If the intended procedure is not completed
- If complications such as abdominal perforation or bleeding have occurred or are suspected
- If it is judged as severe acute pancreatitis with multi-organ failure la.
- When PEP has occurred, but additional imaging tests and endoscopy for diagnosis of the underlying disease or treatment of complications of the patient are required, and fasting is necessary regardless of this study
- Patients with a history of chronic pancreatitis
- Pregnant women, lactating women
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
South Korea9 sites, 9 recruiting
- Recruiting
Korea University Ansan Hospital
Ansan-si
Jung Wan Choe
- Recruiting
Pusan National University Hospital
Busan
Sung Yong Han
- Recruiting
Gyeongsang National University Changwon Hospital
Changwon
Jae Min Lee
- Recruiting
Kyungpook National University School of Medicine
Daegu
Dong Kee Jang
- Recruiting
Gachon University College of Medicine
Incheon
Eui Joo Kim
- Recruiting
Yonsei University College of Medicine
Seoul, 03722
JUNGHYUN JO, +82-2-2228-2274, junghyunjo83@yuhs.ac
- Recruiting
Seoul Metropolitan Government Boramae Medical Center
Seoul
Dong Kee Jang
- Recruiting
Seoul National University Hospital
Seoul
Sang Hyub Lee
- Recruiting
Seoul St. Mary's Hospital
Seoul
Young Hoon Choi
About this study
Official title: Timing of Oral Refeeding in Post-ERCP Pancreatitis
Endoscopic retrograde cholangio-pancreatography (ERCP) is the most commonly used technique for diagnosis and treatment in the treatment of bile duct diseases including bile duct cholelithiasis and malignant/benign biliary obstruction. In particular, ERCP is an essential procedure for the removal of bile duct gallstones and bile drainage in malignant/benign biliary obstruction patients.
Among ERCP-related complications, especially "post-ERCP pancreatitis (PEP)", which occurs due to the anatomical structure of the pancreatic biliary system, statistically occurs in about 5-10% of patients who first received ERCP. It is known, and treatment for PEP is the same as treatment for general acute pancreatitis but is known to have a relatively worse prognosis.
Read more
The basis of treatment for acute pancreatitis is a conservative treatment based on fasting and fluid treatment, and starting oral diet after abdominal pain and pancreatic enzyme levels (amylase/lipase) normalized. However, a recent study reported that early oral diet could improve the patient's prognosis. According to a systematic review of 11 randomized trial papers by Valerie et al., it was reported that the early diet had the effect of reducing hospital stay without increasing adverse events when comparing the prognosis of the early refeeding group and delayed refeeding group. This result is theoretically considered to be because the oral diet has the advantage of increasing intestinal permeability, gut motility and reducing the likelihood of pancreatic necrosis/ infection compared to the parenteral diet.
As above, PEP has the same treatment method as general acute pancreatitis but is known to have a relatively worse prognosis. However, the effect of an early diet recently attempted in acute pancreatitis has not been reported in patients with PEP. Therefore, we investigate the effects of early and delayed diets on the prognosis of patients with PEP through a prospective multicenter study.
Read the detailed description
- Selection of research subjects A total of 80 patients, who have occurred pancreatitis after ERCP, will be enrolled at Yonsei University Sinchon Severance Hospital, Seoul National University Hospital, Dongguk University Ilsan Hospital, Gachon University Gil Hospital, Gyeongsang National University Changwon Hospital, Kyungpook National University Hospital, Seoul St. Mary's Hospital, Korea University Ansan Hospital, Pusan National University Hospital. The purpose and contents of this clinical trial are informed in detail to the subject and consent is obtained.
- Evaluation of eligibility Eligibility is determined based on the basic patient data including physical examination, vital signs, body measurements, medical history, concomitant drugs, laboratory tests, and other basic examinations made at the first visit.
- Grouping and randomization After ERCP was performed, the study subjects who were judged to have PEP according to enroll criteria were divided into early and delayed refeeding groups using a random number table and assigned 1:1 to proceed with the study.
- Timing of refeeding In the early refeeding group, oral diet is started 24 hours after PEP is confirmed. In the delayed refeeding group, oral diet is started after confirmation of restoring of normal bowel sound, pain decreasing below VAS 2. The oral diet starts with SOW (Sips of water) and builds up sequentially in the order of clear liquid diet-soft diet, considering patient tolerability.
- Interruption of refeeding In both early and delayed refeeding groups, the oral diet is stopped when the pain scale the patient complains after starting oral diet increases to VAS 5 points or more, or the patient refuses to eat due to abdominal pain or other reasons. The diet is restarted after the amylase/lipase level decreases below the upper normal limit, the patient's pain has disappeared, and the bowel movement is restored.
- Dropout criteria
- In the case of delayed diet group when symptoms persist for more than 96 hours and cannot start a diet
- When fasting is necessary for other reason, such as an imaging test or endoscopy
- When it is determined that a parenteral diet is necessary for reasons such as difficulty swallowing
- When the researcher judged that the clinical trial cannot be continued
- Discharge criteria and hospitalization period for PEP If the patient is tolerable for more than 24 hours after the soft diet (abdominal pain improvement, lab amylase/lipase level decreases to less than 2 times the upper normal limit, it is judged that PEP has improved and the discharge criteria have been satisfied. From the point of diagnosis of PEP to the point of time when the discharge criteria are satisfied is defined as the "hospitalization period for PEP".
- Conditions
- Post-ERCP Pancreatitis
- Being tested
- early refeeding, delayed refeeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early refeedingOther
In the early refeeding group, oral diet is started 24 hours after PEP is confirmed. The oral diet starts with SOW (Sips of water) and builds up sequentially in the order of clear liquid diet-soft diet, considering patient tolerability.
delayed refeedingOther
In the delayed refeeding group, oral diet is started after confirmation of restoring of normal bowel sound, pain decreasing below VAS 2. The oral diet starts with SOW (Sips of water) and builds up sequentially in the order of clear liquid diet-soft diet, considering patient tolerability.
| Study group | Role | What they receive |
|---|---|---|
| early refeeding group | Experimental | In the early refeeding group, oral diet is started 24 hours after PEP is confirmed. Receives: Other: early refeeding |
| delayed refeeding group | Active comparator | In the delayed refeeding group, oral diet is started after confirmation of restoring of normal bowel sound, pain decreasing below VAS 2. Receives: Other: delayed refeeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
hospitalization period for PEP
If the patient is tolerable for more than 24 hours after the soft diet (abdominal pain improvement, lab amylase/lipase level decreases to less than 2 times the upper normal limit, it is judged that PEP has improved and the discharge criteria have been satisfied. From the point of diagnosis of PEP to the point of time when the discharge criteria are satisfied is defined as the "hospitalization period for PEP".
Measured: up to 1 month
Secondary outcomes (4)
Incidence of acute severe pancreatitis
comparing rate of incidence of severe acute pancreatitis
Measured: up to 1 month
readmission rate (<30 days)
comparing readmission rate of each group until 30 days after discharge
Measured: up to 1 month
mortality rate
comparing mortality rat of each group during hospitalization
Measured: up to 1 month
complication rate
comparing complication rate including nausea/vomiting, recurrent abdominal pain, necrotizing pancreatitis of each group during hospitalization
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start18 Feb 2021
- Primary completion10 Nov 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
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 PancreatitisStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jung Hyun Jo, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04750044
- Sponsor's protocol ID
- 4-2020-1237
- Status last verified
- Oct 2022
- First submitted
- 7 Feb 2021
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jo JH, Lee JM, Jang DK, Choe JW, Han SY, Choi YH, Kim EJ, Kim HY, Jung MK, Lee SH. Early Oral Refeeding in Patients with Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis: A Randomized Controlled Trial. Gut Liver. 2025 Nov 15;19(6):900-908. doi: 10.5009/gnl250110. Epub 2025 Aug 25.
PubMed 40852738
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Oral Refeeding in Post-ERCP Pancreatitis
- ClinicalTrials.gov ID
- NCT04750044
- Acronym / sponsor ID
- 4-2020-1237
- Conditions
- Post-ERCP Pancreatitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 10 Nov 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 11 Feb 2021 (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.
Endoscopic retrograde cholangio-pancreatography (ERCP) is the most commonly used technique for diagnosis and treatment in the treatment of bile duct diseases including bile duct cholelithiasis and malignant/benign biliary obstruction. In particular, ERCP is an essential procedure for the removal of bile duct gallstones and bile drainage in malignant/benign biliary obstruction patients.
Among ERCP-related complications, especially "post-ERCP pancreatitis (PEP)", which occurs due to the anatomical structure of the pancreatic biliary system, statistically occurs in about 5-10% of patients who first received ERCP. It is known, and treatment for PEP is the same as treatment for general acute pancreatitis but is known to have a relatively worse prognosis.
The basis of treatment for acute pancreatitis is a conservative treatment based on fasting and fluid treatment, and starting oral diet after abdominal pain and pancreatic enzyme levels (amylase/lipase) normalized. However, a recent study reported that early oral diet could improve the patient's prognosis. According to a systematic review of 11 randomized trial papers by Valerie et al., it was reported that the early diet had the effect of reducing hospital stay without increasing adverse events when comparing the prognosis of the early refeeding group and delayed refeeding group. This result is theoretically considered to be because the oral diet has the advantage of increasing intestinal permeability, gut motility and reducing the likelihood of pancreatic necrosis/ infection compared to the parenteral diet.
As above, PEP has the same treatment method as general acute pancreatitis but is known to have a relatively worse prognosis. However, the effect of an early diet recently attempted in acute pancreatitis has not been reported in patients with PEP. Therefore, we investigate the effects of early and delayed diets on the prognosis of patients with PEP through a prospective multicenter study.
Detailed description
- Selection of research subjects A total of 80 patients, who have occurred pancreatitis after ERCP, will be enrolled at Yonsei University Sinchon Severance Hospital, Seoul National University Hospital, Dongguk University Ilsan Hospital, Gachon University Gil Hospital, Gyeongsang National University Changwon Hospital, Kyungpook National University Hospital, Seoul St. Mary's Hospital, Korea University Ansan Hospital, Pusan National University Hospital. The purpose and contents of this clinical trial are informed in detail to the subject and consent is obtained.
- Evaluation of eligibility Eligibility is determined based on the basic patient data including physical examination, vital signs, body measurements, medical history, concomitant drugs, laboratory tests, and other basic examinations made at the first visit.
- Grouping and randomization After ERCP was performed, the study subjects who were judged to have PEP according to enroll criteria were divided into early and delayed refeeding groups using a random number table and assigned 1:1 to proceed with the study.
- Timing of refeeding In the early refeeding group, oral diet is started 24 hours after PEP is confirmed. In the delayed refeeding group, oral diet is started after confirmation of restoring of normal bowel sound, pain decreasing below VAS 2. The oral diet starts with SOW (Sips of water) and builds up sequentially in the order of clear liquid diet-soft diet, considering patient tolerability.
- Interruption of refeeding In both early and delayed refeeding groups, the oral diet is stopped when the pain scale the patient complains after starting oral diet increases to VAS 5 points or more, or the patient refuses to eat due to abdominal pain or other reasons. The diet is restarted after the amylase/lipase level decreases below the upper normal limit, the patient's pain has disappeared, and the bowel movement is restored.
- Dropout criteria
- In the case of delayed diet group when symptoms persist for more than 96 hours and cannot start a diet
- When fasting is necessary for other reason, such as an imaging test or endoscopy
- When it is determined that a parenteral diet is necessary for reasons such as difficulty swallowing
- When the researcher judged that the clinical trial cannot be continued
- Discharge criteria and hospitalization period for PEP If the patient is tolerable for more than 24 hours after the soft diet (abdominal pain improvement, lab amylase/lipase level decreases to less than 2 times the upper normal limit, it is judged that PEP has improved and the discharge criteria have been satisfied. From the point of diagnosis of PEP to the point of time when the discharge criteria are satisfied is defined as the "hospitalization period for PEP".
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early refeeding group | Experimental | Other: early refeedingIn the early refeeding group, oral diet is started 24 hours after PEP is confirmed. |
| delayed refeeding group | Active comparator | Other: delayed refeedingIn the delayed refeeding group, oral diet is started after confirmation of restoring of normal bowel sound, pain decreasing below VAS 2. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 20 to 80
- As patients who developed pancreatitis after receiving ERCP, the following must be satisfied at the same time.
Key exclusion criteria (6 listed)
- If the intended procedure is not completed
- If complications such as abdominal perforation or bleeding have occurred or are suspected
- If it is judged as severe acute pancreatitis with multi-organ failure la.
- When PEP has occurred, but additional imaging tests and endoscopy for diagnosis of the underlying disease or treatment of complications of the patient are required, and fasting is necessary regardless of this study
- Patients with a history of chronic pancreatitis
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 |
|---|---|---|
| early refeedingIn the early refeeding group, oral diet is started 24 hours after PEP is confirmed. The oral diet starts with SOW (Sips of water) and builds up sequentially in the order of clear liquid diet-soft diet, considering patient tolerability. | Other | early refeeding group |
| delayed refeedingIn the delayed refeeding group, oral diet is started after confirmation of restoring of normal bowel sound, pain decreasing below VAS 2. The oral diet starts with SOW (Sips of water) and builds up sequentially in the order of clear liquid diet-soft diet, considering patient tolerability. | Other | delayed refeeding group |
Primary outcome
hospitalization period for PEP
Time frame: up to 1 month
If the patient is tolerable for more than 24 hours after the soft diet (abdominal pain improvement, lab amylase/lipase level decreases to less than 2 times the upper normal limit, it is judged that PEP has improved and the discharge criteria have been satisfied. From the point of diagnosis of PEP to the point of time when the discharge criteria are satisfied is defined as the "hospitalization period for PEP".
4 secondary outcomes
Incidence of acute severe pancreatitis
Time frame: up to 1 month
readmission rate (<30 days)
Time frame: up to 1 month
mortality rate
Time frame: up to 1 month
complication rate
Time frame: up to 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Derived from this study: PubMed 40852738Jo JH, Lee JM, Jang DK, Choe JW, Han SY, Choi YH, Kim EJ, Kim HY, Jung MK, Lee SH. Early Oral Refeeding in Patients with Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis: A Randomized Controlled Trial. Gut Liver. 2025 Nov 15;19(6):900-908. doi: 10.5009/gnl250110. Epub 2025 Aug 25.
- 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.
Jung Hyun Jo principal investigator
Severance Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing early refeeding and delayed refeeding in people with Post-ERCP Pancreatitis, run by Yonsei University at 9 sites 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jung Hyun Jo (+82-2-2228-2274, junghyunjo83@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hospitalization period for PEP (time frame: up to 1 month). 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 NCT04750044, 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 26 Oct 2022.