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Inmediate Feeding Tolerance in Acute Pancreatitis

Sponsor
Hospital Central "Dr. Ignacio Morones Prieto" (Other)
Overall Status
Completed
CT.gov ID
NCT03354065
Collaborator
(none)
59
Enrollment
2
Arms
8
Actual Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: TIME OF FEEDING
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
59 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
blinding of the evaluator to the study group blinding of patient to study hypothesis
Primary Purpose:
Treatment
Official Title:
Inmediate Feeding Tolerance in Patients With Mild and Acute Biliary Pancreatitis vs Early Feeding
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Jul 1, 2017
Actual Study Completion Date :
Aug 31, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Early oral feeding

TIME OF FEEDING. 48 hours after pancreatitis general management is started ( liquid diet)

Dietary Supplement: TIME OF FEEDING
Liquid ( Re Feeding 8 h ) OR Enteral Feeding ( re feeding 48 h)
Experimental: Immediate oral feeding

TIME OF FEEDING: 8 hours of after pancreatitis general management is started (enteral formula)

Dietary Supplement: TIME OF FEEDING
Liquid ( Re Feeding 8 h ) OR Enteral Feeding ( re feeding 48 h)

Outcome Measures

Primary Outcome Measures

  1. Pancreatitis reactivation after oral Feeding [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Hospital Central "Dr. Ignacio Morones Prieto"

Investigators

  • Study Chair: Juan F Hernandez, Postgraduate office at UASLP

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
David Esmer, head of the surgery service of Central Hospital, SLP, Mex, Hospital Central "Dr. Ignacio Morones Prieto"
ClinicalTrials.gov Identifier:
NCT03354065
Other Study ID Numbers:
  • 07-15
First Posted:
Nov 27, 2017
Last Update Posted:
Nov 27, 2017
Last Verified:
Nov 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by David Esmer, head of the surgery service of Central Hospital, SLP, Mex, Hospital Central "Dr. Ignacio Morones Prieto"
pancreatitis
mild
biliary
referring
Additional relevant MeSH terms:
Pancreatitis
Gallstones

Study Results

No Results Posted as of Nov 27, 2017