Early feeding after endoscopic retrograde cholangio-pancreatography

Clinical safety and patient satisfaction of early re-feeding based on evaluation at 4 hours after endoscopic retrograde cholangio-pancreatography: A prospective randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002354

Enrollment

276

Registered

2017-06-13

Start date

2015-07-22

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : Patients in the early diet group started oral intake 4 hours after ERCP of the day of procedure with a soft diet comprised 300 mL with 170 kilocalories. Subsequently, the diet was

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients were eligible to enter the study if they were 18 years of age or older, American Society of Anesthesiology (ASA) risk class I, II or III, and scheduled for ERCP only.

Exclusion criteria

Exclusion criteria: Exclusion criteria were as follows: (1) acute pancreatitis during the 2 weeks before ERCP; (2) a history of chronic pancreatitis; (3) non-naïve major papilla such as previous sphincterotomy, pancreatic sphincterotomy or balloon dilatation; (4) the major papilla could not be reached becaused of anatomical or surgical alteration (total gastrectomy with Roux en Y anastomosis, choledocho-jejunostomy or hepatico-jejunostomy); (5) a 1.5-fold or more hyperamylasemia at 4 hours after ERCP; (6) immediately bleeding, perforation, suspected cholecystitis or cholangitis within 4 hours after ERCP; (7) refusal to participate in the study or declining to provide informed consent. Patients with a confirmed pregnancy and those who were breastfeeding were also excluded. Finally, patients were excluded if they underwent ERCP on an outpatient basis, for procedures such as stone removal following previous sphincterotomy, change or removal of previous plastic biliary stents, or surveillance biopsy after endoscopic papillectomy without pancreatocholangiography, which are considered to carry minimal potential risks of PEP.

Design outcomes

Primary

Measure	Time frame
the incidence of post ERCP pancreatitis	—

Secondary

Measure	Time frame
the length of hospitalization;the medical expenses for ERCP treatment;the diagnostic accuracy for prediction of PEP based on amylase levels 4 hours after ERCP	—

Countries

Korea, Republic of

Contacts

Public ContactSe Woo Park

Hallym University Medical Center-Dongtan

britnepak@outlook.com+82-2-8086-2858

Outcome results