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Inmediate Feeding Tolerance in Acute Pancreatitis

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ClinicalTrials.gov Identifier: NCT03354065
Recruitment Status : Completed
First Posted : November 27, 2017
Last Update Posted : November 27, 2017
Sponsor:
Information provided by (Responsible Party):
David Esmer, 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


Condition or disease Intervention/treatment Phase
Acute Pancreatitis Due to Gallstones Dietary Supplement: TIME OF FEEDING Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : January 1, 2017
Actual Primary Completion Date : July 1, 2017
Actual Study Completion Date : August 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

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)




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03354065


Sponsors and Collaborators
Hospital Central "Dr. Ignacio Morones Prieto"
Investigators
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Study Chair: Juan F Hernandez Postgraduate office at UASLP
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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: November 27, 2017    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Esmer, Hospital Central "Dr. Ignacio Morones Prieto":
pancreatitis
mild
biliary
referring
Additional relevant MeSH terms:
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Pancreatitis
Gallstones
Pancreatic Diseases
Digestive System Diseases
Cholelithiasis
Biliary Tract Diseases
Cholecystolithiasis
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical