Inmediate Feeding Tolerance in Acute Pancreatitis

Acute Pancreatitis Due to Gallstones Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03354065
• Other study ID #: 07-15
• Status: Completed
• Phase: N/A
• First received: October 27, 2017
• Last updated: November 23, 2017
• Start date: January 1, 2017
• Est. completion date: August 31, 2017

Study information

• Verified date: November 2017
• Source: Hospital Central "Dr. Ignacio Morones Prieto"
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: August 31, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pancreatitis Due to Gallstones
• Gallstones
• Pancreatitis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Central "Dr. Ignacio Morones Prieto"

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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