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Completed

NCT Number: NCT03354065

Inmediate Feeding Tolerance in Acute Pancreatitis

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

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Key information

Conditions

Acute Pancreatitis Due to Gallstones Digestive System Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pancreatic Diseases Pancreatitis

Age range

15 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TIME OF FEEDING

Dietary Supplement

Liquid ( Re Feeding 8 h ) OR Enteral Feeding ( re feeding 48 h)

Primary outcomes

  1. Pancreatitis reactivation after oral Feeding

    Time frame: Measures at 24hours 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

  2. Pancreatitis reactivation after oral Feeding

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospital Central "Dr. Ignacio Morones Prieto"

Other

Registry information

Official study title

Inmediate Feeding Tolerance in Patients With Mild and Acute Biliary Pancreatitis vs Early Feeding

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 27, 2017
Registry last updated
Nov 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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