Acute Pancreatitis Due to GallstonesNCT03354065
Inmediate Feeding Tolerance in Acute Pancreatitis
A study testing TIME OF FEEDING in people with Acute Pancreatitis Due to Gallstones, run by Hospital Central "Dr. Ignacio Morones Prieto".
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 Read more about this study
- Who is it for?
- Ages 15 to 85 years
- Conditions the study is for
- Acute Pancreatitis Due to Gallstones
- What is being tested?
- TIME OF FEEDING
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients older than 15 years.
- Patients with a diagnosis of mild acute pancreatitis biliary.
- Patients who agree to enter the protocol.
Who cannot join
- 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.
About this study
Official title: Inmediate Feeding Tolerance in Patients With Mild and Acute Biliary Pancreatitis vs Early Feeding
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
Read the 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.
- Conditions
- Acute Pancreatitis Due to Gallstones
- Being tested
- TIME OF FEEDING
- Keywords
- pancreatitis, mild, biliary, referring
- Medical subject headings
- Pancreatitis, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIME OF FEEDINGDietary supplement
Liquid ( Re Feeding 8 h ) OR Enteral Feeding ( re feeding 48 h)
| Study group | Role | What they receive |
|---|---|---|
| Early oral feeding | Active comparator | TIME OF FEEDING. 48 hours after pancreatitis general management is started ( liquid diet) Receives: Dietary Supplement: TIME OF FEEDING |
| Immediate oral feeding | Experimental | TIME OF FEEDING: 8 hours of after pancreatitis general management is started (enteral formula) Receives: Dietary Supplement: TIME OF FEEDING |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Measures at 48hours after the begining of the oral intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start1 Jan 2017
- Primary completion1 Jul 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Pancreatitis Due to GallstonesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Central "Dr. Ignacio Morones Prieto"
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Esmer, Hospital Central "Dr. Ignacio Morones Prieto"
- Investigators
- Juan F Hernandez, Study chair, Postgraduate office at UASLP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03354065
- Sponsor's protocol ID
- 07-15
- Status last verified
- Nov 2017
- First submitted
- 27 Oct 2017
- Last updated
- 27 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inmediate Feeding Tolerance in Patients With Mild and Acute Biliary Pancreatitis vs Early Feeding
- ClinicalTrials.gov ID
- NCT03354065
- Acronym / sponsor ID
- 07-15
- Conditions
- Acute Pancreatitis Due to Gallstones
- Keywords
- pancreatitis, mild, biliary, referring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Hospital Central "Dr. Ignacio Morones Prieto"University, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 27 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early oral feeding | Active comparator | Dietary Supplement: TIME OF FEEDINGTIME OF FEEDING. 48 hours after pancreatitis general management is started ( liquid diet) |
| Immediate oral feeding | Experimental | Dietary Supplement: TIME OF FEEDINGTIME OF FEEDING: 8 hours of after pancreatitis general management is started (enteral formula) |
Who may qualify
- Ages
- 15 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients older than 15 years.
- Patients with a diagnosis of mild acute pancreatitis biliary.
- Patients who agree to enter the protocol.
Key exclusion criteria (6 listed)
- Patients managed at another institution.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TIME OF FEEDINGLiquid ( Re Feeding 8 h ) OR Enteral Feeding ( re feeding 48 h) | Dietary supplement | Early oral feeding, Immediate oral feeding |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2017.
- Individual participant dataSharing planned: No
Related trials for Acute Pancreatitis Due to Gallstones
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Ursodeoxycolic Acid for the Prevention of Relapsing Complications After Gallstone Acute Pancreatitis
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Enrolling by invitation
PrEveNtion of Biliary Events After Acute Pancreatitis in NonSUrgicaL PAtients: PENINSULA Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan F Hernandez study chair
Postgraduate office at UASLP
Questions about this trial
What is this clinical trial studying?
A study testing TIME OF FEEDING in people with Acute Pancreatitis Due to Gallstones, run by Hospital Central "Dr. Ignacio Morones Prieto".
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pancreatitis reactivation after oral Feeding (time frame: Measures at 24hours after the begining of the oral intake). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2017.