Refeeding in Post-ERCP Pancreatitis

NCT04750044 | Unknown

• 1 other identifier: 4-2020-1237
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 9

Brief 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. 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.

Conditions

Post-ERCP Pancreatitis

Outcome Measures

Primary Outcomes (1)

• 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".

  up to 1 month

Secondary Outcomes (4)

• Incidence of acute severe pancreatitis

  up to 1 month

• readmission rate (<30 days)

  up to 1 month

• mortality rate

  up to 1 month

• complication rate

  up to 1 month

Study Arms (2)

early refeeding group

EXPERIMENTAL

In the early refeeding group, oral diet is started 24 hours after PEP is confirmed.

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.

Other: delayed refeeding

Interventions

early refeeding OTHER

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.

early refeeding group

delayed refeeding OTHER

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.

delayed refeeding group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (9)

Korea University Ansan Hospital

Ansan-si, South Korea

RECRUITING

Pusan National University Hospital

Busan, South Korea

RECRUITING

Gyeongsang National University Changwon Hospital

Changwon, South Korea

RECRUITING

Kyungpook National University School of Medicine

Daegu, South Korea

RECRUITING

Gachon University College of Medicine

Incheon, South Korea

RECRUITING

Yonsei University College of Medicine

Seoul, 03722, South Korea

RECRUITING

Seoul Metropolitan Government Boramae Medical Center

Seoul, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Seoul St. Mary's Hospital

Seoul, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 40852738 DERIVED

Study Officials

• Jung Hyun Jo

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jung Hyun Jo

CONTACT

+82-2-2228-2274; junghyunjo83@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2021
• First Posted: February 11, 2021
• Study Start: February 18, 2021
• Primary Completion: November 10, 2022
• Study Completion: December 30, 2022
• Last Updated: October 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (9)