An interventional study of early refeeding and delayed refeeding in Post-ERCP Pancreatitis, sponsored by Yonsei University. Status unknown at 9 sites in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-10-26.
Sponsored by Yonsei University · Not applicable, Interventional, and Supportive care
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.
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.
Dropout criteria
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This study's planned enrollment of 80 is close to the median of 80 across 448 interventional studies indexed under Pancreatitis.
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As patients who developed pancreatitis after receiving ERCP, the following must be satisfied at the same time.
Exclusion Criteria:
In the early refeeding group, oral diet is started 24 hours after PEP is confirmed.
Other: early refeeding
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
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.
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.
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".
Time frame: up to 1 month
Incidence of acute severe pancreatitis
comparing rate of incidence of severe acute pancreatitis
Time frame: up to 1 month
readmission rate (<30 days)
comparing readmission rate of each group until 30 days after discharge
Time frame: up to 1 month
mortality rate
comparing mortality rat of each group during hospitalization
Time frame: up to 1 month
complication rate
comparing complication rate including nausea/vomiting, recurrent abdominal pain, necrotizing pancreatitis of each group during hospitalization
Time frame: up to 1 month
Plan to share: No
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Yonsei University