Inmediate Feeding Tolerance in Acute Pancreatitis

Not Applicable

Completed

• Conditions: Acute Pancreatitis Due to Gallstones
• Interventions: Dietary Supplement: TIME OF FEEDING

• Registration Number: NCT03354065
• Lead Sponsor: Hospital Central "Dr. Ignacio Morones Prieto"

Brief Summary

Objective: Determine tolerance of immediate oral intake (8 hours posterior to the beginning of treatment) against traditional management (early feeding at 48hr) in patients with mild acute pancreatitis of biliary origin.

Double blind, randomized clinical trial

Detailed Description

The investigators included patients 15 - 85 years old, any sex. Diagnosis of mild acute pancreatitis according to the Ranson, APACHE II and BISAP.

Signed infromed consent to participate in the study. All participants had a hepatic and biliary ultrasound to determine the biliary etiology.

The investigators excluded patients with pancreatitis of nonbiliary etiology, pregnant, severe pancreatitis, cholangitis or choledocholithiasis demonstrated during the hospital stay or with other comorbidities.

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2017-07-01
• Study Completion: 2017-08-31
• Study First Submitted: 2017-10-27
• Status Verified: 2017-11
• Study First Submitted QC: 2017-11-23
• Last Update Submitted: 2017-11-23
• Study First Posted: 2017-11-27
• Last Update Posted: 2017-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

Patients older than 15 years.

• Patients with a diagnosis of mild acute pancreatitis biliary.
• Patients who agree to enter the protocol.

Exclusion Criteria

• Patients managed at another institution.

  • Patients with a diagnosis of pancreatitis of non-biliary etiology.
  • Patients with heart disease or lung disease.
  • Patients with organic failure.
  • Patients with pregnancy.
  • Patients with cholangitis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early oral feeding	TIME OF FEEDING	TIME OF FEEDING. 48 hours after pancreatitis general management is started ( liquid diet)
Immediate oral feeding	TIME OF FEEDING	TIME OF FEEDING: 8 hours of after pancreatitis general management is started (enteral formula)

Primary Outcome Measures

Name	Time	Method
Pancreatitis reactivation after oral Feeding	Measures at 48hours after the begining of the oral intake	Resurgence of characteristically epigastric tansfictive pain, irradiated to the left, upper quadrant region after beginning the oral intake, systemic inflammatory response syndrome ( C reactive protein) or Significant leucocyte elevation