Inmediate Feeding Tolerance in Acute Pancreatitis

NCT03354065 | Completed

• 1 other identifier: 07-15
• Study Type: interventional
• Target: 59
• Locations: 0 countries
• Sites: N/A

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

Conditions

Acute Pancreatitis Due to Gallstones

Keywords

pancreatitis; mild; biliary; referring

Outcome Measures

Primary Outcomes (2)

• Pancreatitis reactivation after oral Feeding

  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

  Measures at 24hours after the begining of the oral intake

• Pancreatitis reactivation after oral Feeding

  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

  Measures at 48hours after the begining of the oral intake

Study Arms (2)

Early oral feeding

ACTIVE COMPARATOR

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

Dietary Supplement: TIME OF FEEDING

Immediate oral feeding

EXPERIMENTAL

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

Dietary Supplement: TIME OF FEEDING

Interventions

TIME OF FEEDING DIETARY_SUPPLEMENT

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

Early oral feeding; Immediate oral feeding

Eligibility Criteria

• Age: 15 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 15 years.
• Patients with a diagnosis of mild acute pancreatitis biliary.
• Patients who agree to enter the protocol.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Central "Dr. Ignacio Morones Prieto": lead

MeSH Terms

Conditions

Pancreatitis; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Juan F Hernandez

  Postgraduate office at UASLP

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: blinding of the evaluator to the study group blinding of patient to study hypothesis
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of the surgery service of Central Hospital, SLP, Mex

Study Record Dates

• First Submitted: October 27, 2017
• First Posted: November 27, 2017
• Study Start: January 1, 2017
• Primary Completion: July 1, 2017
• Study Completion: August 31, 2017
• Last Updated: November 27, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share