<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03829085</url>
  </required_header>
  <id_info>
    <org_study_id>PADI_01</org_study_id>
    <nct_id>NCT03829085</nct_id>
  </id_info>
  <brief_title>Study of the Diet in Patients With the Diagnostic of Acute Pancreatitis</brief_title>
  <acronym>PADI</acronym>
  <official_title>Randomized Multicenter Prospective Clinical Trial to Compare the Effectiveness of Starting Early Oral Diet Versus Nil Per Oral in Patients With Acute Pancreatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Consorci Sanitari del Garraf</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Universitari Joan XXIII de Tarragona.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Clinic of Barcelona</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Consorci Sanitari del Garraf</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acute pancreatitis (AP) is a common condition in emergency services worldwide. Approximately&#xD;
      85% of AP are mild and the patients usually recover within 1 to 2 weeks, not requeiring any&#xD;
      critical care and organ support. The management of mild AP conventionally involves fasting,&#xD;
      intravenous hydration and adequate analgesia until pain improves in order to prevent&#xD;
      stimulation and allow the pancreas gland to rest.&#xD;
&#xD;
      The current guidelines recommend the oral food intake should be tried as soon as possible,&#xD;
      and beneficial effects or early enteral nutrition with mild AP have been reported in&#xD;
      literature.&#xD;
&#xD;
      Then, early oral refeeding (EORF) after mild and moderate AP is beneficial, but the optimal&#xD;
      timing and starting criteria are unclear. Even now, refeeding after mild and moderate AP is&#xD;
      typically started until clinical symptoms have resolved and pancreatic enzymes are&#xD;
      decreasing, in a successively increasing manner. The aim of this study is to evaluate length&#xD;
      of hospital stay, clinical findings and complications for EORF with immediately full caloric&#xD;
      intake in patients with mild and moderate AP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is prospective, randomized, controlled, multicentre trial. Patients with mild and&#xD;
      moderate acute pancreatitis (AP) will be randomly in two groups: group A: with early oral&#xD;
      refeeding (EOR) with low fat solid diet (LFSD), started from the first day of admission in&#xD;
      the hospital, and group B: with Nil Per Oral (NPO), until the symptoms, signs, inflammatory&#xD;
      parameters of AP have resolved.&#xD;
&#xD;
      The primary and several secondary endpoints will be obtained and EORF with LFSD will improve&#xD;
      the following measures of outcome:&#xD;
&#xD;
        1. Length of hospital admission (the primary endpoint)&#xD;
&#xD;
        2. Serum amylase, lipase, electrolytes, calcium, urea, creatinine, liver function tests,&#xD;
           C-reactive protein (biomarker of inflammation), nutritional parameters (albumin,&#xD;
           prealbumin, cholesterol, triglycerides) and full blood count - routine blood tests&#xD;
           performed daily until normalization of serum lipase or until discharge.&#xD;
&#xD;
        3. Weight, at hospital admission and discharge, and at day 30 post-discharge clinic&#xD;
           follow-up.&#xD;
&#xD;
        4. Systemic complications including hemodynamic instability, renal failure, intensive care&#xD;
           admission, surgery, radiological and endoscopic procedures.&#xD;
&#xD;
        5. Pain and Analgesic requirement.&#xD;
&#xD;
        6. Local complications including pancreatic necrosis, abscess, pseudocyst.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Length of hospitalization</measure>
    <time_frame>measured from onset of admission until time of actual discharge from hospital. Assessed between 1-10 days up to 14 days.</time_frame>
    <description>Days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Relapse of abdominal pain</measure>
    <time_frame>measured from onset of admission until time of actual discharge from hospital. Assessed between 1-10 days up to 14 days, and during the follow up (1 month after discharge)</time_frame>
    <description>Pain Scale: 0=No pain, 1=Very mild, 2=Discomforting, 3=Tolerable, 4=Distressing, 5=Distressing, 6=Intense pain, 7=Very intense pain, 8=Horrible pain, 9=Excruciating, 10=Unimaginable pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of fasting</measure>
    <time_frame>2-3 days approximately since the first day of hospital admission</time_frame>
    <description>Days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerance to food</measure>
    <time_frame>2-7 days approximately during hospital admission and during the follow up</time_frame>
    <description>The patient's symptoms are controlled with the established treatment and the patient can eat at least 50% of the meals</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elevation of serum amylase or lipase</measure>
    <time_frame>2-4 days approximately during hospital admission after oral refeeding, until hospital discharge</time_frame>
    <description>Elevation amylase or lipase level after oral refeeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intra-abdominal infection</measure>
    <time_frame>1 month</time_frame>
    <description>Fever: temperature greater than 38 or positive cultures of blood or pancreatic necrosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death</measure>
    <time_frame>During hospital stay (up to 1 day)</time_frame>
    <description>Mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operation rate</measure>
    <time_frame>2 month</time_frame>
    <description>The rate of patients received operation for pancreatitis debridement</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Pancreatitis, Acute</condition>
  <arm_group>
    <arm_group_label>Early oral refeeding</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients will be started the oral refeeding from the first day of admission in the hospital.&#xD;
Patients will receive a low fat solid diet with more and less 1500 calories, 35 g fat day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FASTING</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The oral diet will be reintroduced in a traditional stepwise manner until the symptoms, signs, inflammatory parameters of AP have resolved</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>EARLY ORAL REFEEDING</intervention_name>
    <description>the oral refeeding will be started after admission. Patients will receive a low fat solid diet with more and less 1500 calories, 35 g fat day</description>
    <arm_group_label>Early oral refeeding</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1) Diagnosed of AP by at least two of these three criteria: compatible abdominal pain,&#xD;
             amylase or lipase level superior in three-fold respective laboratory baseline levels,&#xD;
             and suitable findings in imaging techniques (CT, ultrasound or MRI)&#xD;
&#xD;
          -  2) age &gt; 18 years, sign consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1) pregnant o breastfeeding women;&#xD;
&#xD;
          -  2) abdominal pain lasting &gt;96 horas before admission;&#xD;
&#xD;
          -  3) the possibility of poor oral intake for reasons other than AP;&#xD;
&#xD;
          -  4) Pancreatic neoplasm, endoscopic retrograde cholangiopancreatography or trauma&#xD;
             etiology;&#xD;
&#xD;
          -  5) Chronic pancreatitis;&#xD;
&#xD;
          -  6) Randomization greater the 12 hours after admission&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elena Ramírez-Maldonado, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Consorcio Sanitari del Garraf</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Consorci Sanitari del Garraf</name>
      <address>
        <city>Sant Pere De Ribes</city>
        <state>Barcelona</state>
        <zip>08810</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Greenberg JA, Hsu J, Bawazeer M, Marshall J, Friedrich JO, Nathens A, Coburn N, May GR, Pearsall E, McLeod RS. Clinical practice guideline: management of acute pancreatitis. Can J Surg. 2016 Apr;59(2):128-40. doi: 10.1503/cjs.015015.</citation>
    <PMID>27007094</PMID>
  </reference>
  <reference>
    <citation>Tenner S, Baillie J, DeWitt J, Vege SS; American College of Gastroenterology. American College of Gastroenterology guideline: management of acute pancreatitis. Am J Gastroenterol. 2013 Sep;108(9):1400-15; 1416. doi: 10.1038/ajg.2013.218. Epub 2013 Jul 30. Erratum In: Am J Gastroenterol. 2014 Feb;109(2):302.</citation>
    <PMID>23896955</PMID>
  </reference>
  <reference>
    <citation>Bevan MG, Asrani VM, Bharmal S, Wu LM, Windsor JA, Petrov MS. Incidence and predictors of oral feeding intolerance in acute pancreatitis: A systematic review, meta-analysis, and meta-regression. Clin Nutr. 2017 Jun;36(3):722-729. doi: 10.1016/j.clnu.2016.06.006. Epub 2016 Jun 16.</citation>
    <PMID>27346178</PMID>
  </reference>
  <results_reference>
    <citation>Lodewijkx PJ, Besselink MG, Witteman BJ, Schepers NJ, Gooszen HG, van Santvoort HC, Bakker OJ; Dutch Pancreatitis Study Group. Nutrition in acute pancreatitis: a critical review. Expert Rev Gastroenterol Hepatol. 2016;10(5):571-80. doi: 10.1586/17474124.2016.1141048. Epub 2016 Mar 15.</citation>
    <PMID>26823272</PMID>
  </results_reference>
  <results_reference>
    <citation>Jacobson BC, Vander Vliet MB, Hughes MD, Maurer R, McManus K, Banks PA. A prospective, randomized trial of clear liquids versus low-fat solid diet as the initial meal in mild acute pancreatitis. Clin Gastroenterol Hepatol. 2007 Aug;5(8):946-51; quiz 886. doi: 10.1016/j.cgh.2007.04.012. Epub 2007 Jul 5.</citation>
    <PMID>17613280</PMID>
  </results_reference>
  <results_reference>
    <citation>Eckerwall GE, Tingstedt BB, Bergenzaun PE, Andersson RG. Immediate oral feeding in patients with mild acute pancreatitis is safe and may accelerate recovery--a randomized clinical study. Clin Nutr. 2007 Dec;26(6):758-63. doi: 10.1016/j.clnu.2007.04.007. Epub 2007 Aug 24.</citation>
    <PMID>17719703</PMID>
  </results_reference>
  <results_reference>
    <citation>Li J, Xue GJ, Liu YL, Javed MA, Zhao XL, Wan MH, Chen GY, Altaf K, Huang W, Tang WF. Early oral refeeding wisdom in patients with mild acute pancreatitis. Pancreas. 2013 Jan;42(1):88-91. doi: 10.1097/MPA.0b013e3182575fb5.</citation>
    <PMID>22836861</PMID>
  </results_reference>
  <results_reference>
    <citation>Olah A, Romics L Jr. Enteral nutrition in acute pancreatitis: a review of the current evidence. World J Gastroenterol. 2014 Nov 21;20(43):16123-31. doi: 10.3748/wjg.v20.i43.16123.</citation>
    <PMID>25473164</PMID>
  </results_reference>
  <results_reference>
    <citation>Petrov MS, van Santvoort HC, Besselink MG, Cirkel GA, Brink MA, Gooszen HG. Oral refeeding after onset of acute pancreatitis: a review of literature. Am J Gastroenterol. 2007 Sep;102(9):2079-84; quiz 2085. doi: 10.1111/j.1572-0241.2007.01357.x. Epub 2007 Jun 16.</citation>
    <PMID>17573797</PMID>
  </results_reference>
  <results_reference>
    <citation>Zhao XL, Zhu SF, Xue GJ, Li J, Liu YL, Wan MH, Huang W, Xia Q, Tang WF. Early oral refeeding based on hunger in moderate and severe acute pancreatitis: a prospective controlled, randomized clinical trial. Nutrition. 2015 Jan;31(1):171-5. doi: 10.1016/j.nut.2014.07.002. Epub 2014 Jul 30.</citation>
    <PMID>25441594</PMID>
  </results_reference>
  <results_reference>
    <citation>Petrov MS, Pylypchuk RD, Uchugina AF. A systematic review on the timing of artificial nutrition in acute pancreatitis. Br J Nutr. 2009 Mar;101(6):787-93. doi: 10.1017/S0007114508123443. Epub 2008 Nov 19.</citation>
    <PMID>19017421</PMID>
  </results_reference>
  <results_reference>
    <citation>Li X, Ma F, Jia K. Early enteral nutrition within 24 hours or between 24 and 72 hours for acute pancreatitis: evidence based on 12 RCTs. Med Sci Monit. 2014 Nov 17;20:2327-35. doi: 10.12659/MSM.892770.</citation>
    <PMID>25399541</PMID>
  </results_reference>
  <results_reference>
    <citation>Larino-Noia J, Lindkvist B, Iglesias-Garcia J, Seijo-Rios S, Iglesias-Canle J, Dominguez-Munoz JE. Early and/or immediately full caloric diet versus standard refeeding in mild acute pancreatitis: a randomized open-label trial. Pancreatology. 2014 May-Jun;14(3):167-73. doi: 10.1016/j.pan.2014.02.008. Epub 2014 Mar 14.</citation>
    <PMID>24854611</PMID>
  </results_reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 27, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>February 1, 2019</last_update_submitted>
  <last_update_submitted_qc>February 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Consorci Sanitari del Garraf</investigator_affiliation>
    <investigator_full_name>Elena Ramírez-Maldonado</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Acute Pancreatitis</keyword>
  <keyword>Oral refeeding</keyword>
  <keyword>Nutrition</keyword>
  <keyword>Length hospitalization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The results of this trial will be published in an open access way and disseminates among medical societies</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>From June 2019 the data will be available until publication</ipd_time_frame>
    <ipd_access_criteria>Open accès publication</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 1, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/85/NCT03829085/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03829085
org study id: PADI_01
nct id: NCT03829085
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Acute pancreatitis (AP) is a common condition in emergency services worldwide. Approximately
      85% of AP are mild and the patients usually recover within 1 to 2 weeks, not requeiring any
      critical care and organ support. The management of mild AP conventionally involves fasting,
      intravenous hydration and adequate analgesia until pain improves in order to prevent
      stimulation and allow the pancreas gland to rest.

      The current guidelines recommend the oral food intake should be tried as soon as possible,
      and beneficial effects or early enteral nutrition with mild AP have been reported in
      literature.

      Then, early oral refeeding (EORF) after mild and moderate AP is beneficial, but the optimal
      timing and starting criteria are unclear. Even now, refeeding after mild and moderate AP is
      typically started until clinical symptoms have resolved and pancreatic enzymes are
      decreasing, in a successively increasing manner. The aim of this study is to evaluate length
      of hospital stay, clinical findings and complications for EORF with immediately full caloric
      intake in patients with mild and moderate AP.
This is prospective, randomized, controlled, multicentre trial. Patients with mild and
      moderate acute pancreatitis (AP) will be randomly in two groups: group A: with early oral
      refeeding (EOR) with low fat solid diet (LFSD), started from the first day of admission in
      the hospital, and group B: with Nil Per Oral (NPO), until the symptoms, signs, inflammatory
      parameters of AP have resolved.

      The primary and several secondary endpoints will be obtained and EORF with LFSD will improve
      the following measures of outcome:

        1. Length of hospital admission (the primary endpoint)

        2. Serum amylase, lipase, electrolytes, calcium, urea, creatinine, liver function tests,
           C-reactive protein (biomarker of inflammation), nutritional parameters (albumin,
           prealbumin, cholesterol, triglycerides) and full blood count - routine blood tests
           performed daily until normalization of serum lipase or until discharge.

        3. Weight, at hospital admission and discharge, and at day 30 post-discharge clinic
           follow-up.

        4. Systemic complications including hemodynamic instability, renal failure, intensive care
           admission, surgery, radiological and endoscopic procedures.

        5. Pain and Analgesic requirement.

        6. Local complications including pancreatic necrosis, abscess, pseudocyst.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Length of hospitalization
time frame: measured from onset of admission until time of actual discharge from hospital. Assessed between 1-10 days up to 14 days.
description: Days
measure: Relapse of abdominal pain
time frame: measured from onset of admission until time of actual discharge from hospital. Assessed between 1-10 days up to 14 days, and during the follow up (1 month after discharge)
description: Pain Scale: 0=No pain, 1=Very mild, 2=Discomforting, 3=Tolerable, 4=Distressing, 5=Distressing, 6=Intense pain, 7=Very intense pain, 8=Horrible pain, 9=Excruciating, 10=Unimaginable pain
measure: Duration of fasting
time frame: 2-3 days approximately since the first day of hospital admission
description: Days
measure: Tolerance to food
time frame: 2-7 days approximately during hospital admission and during the follow up
description: The patient's symptoms are controlled with the established treatment and the patient can eat at least 50% of the meals
measure: Elevation of serum amylase or lipase
time frame: 2-4 days approximately during hospital admission after oral refeeding, until hospital discharge
description: Elevation amylase or lipase level after oral refeeding
measure: Intra-abdominal infection
time frame: 1 month
description: Fever: temperature greater than 38 or positive cultures of blood or pancreatic necrosis
measure: Death
time frame: During hospital stay (up to 1 day)
description: Mortality
measure: Operation rate
time frame: 2 month
description: The rate of patients received operation for pancreatitis debridement
arm group label: Early oral refeeding
arm group type: Active Comparator
description: The patients will be started the oral refeeding from the first day of admission in the hospital.
Patients will receive a low fat solid diet with more and less 1500 calories, 35 g fat day
arm group label: FASTING
arm group type: No Intervention
description: The oral diet will be reintroduced in a traditional stepwise manner until the symptoms, signs, inflammatory parameters of AP have resolved
intervention type: Other
intervention name: EARLY ORAL REFEEDING
description: the oral refeeding will be started after admission. Patients will receive a low fat solid diet with more and less 1500 calories, 35 g fat day
arm group label: Early oral refeeding
criteria: 
gender: All
minimum age: 18 Years
maximum age: 95 Years
healthy volunteers: No
last name: Elena Ramírez-Maldonado, MD
role: Principal Investigator
affiliation: Consorcio Sanitari del Garraf
facility: 
country: Spain
citation: Greenberg JA, Hsu J, Bawazeer M, Marshall J, Friedrich JO, Nathens A, Coburn N, May GR, Pearsall E, McLeod RS. Clinical practice guideline: management of acute pancreatitis. Can J Surg. 2016 Apr;59(2):128-40. doi: 10.1503/cjs.015015.
PMID: 27007094
citation: Tenner S, Baillie J, DeWitt J, Vege SS; American College of Gastroenterology. American College of Gastroenterology guideline: management of acute pancreatitis. Am J Gastroenterol. 2013 Sep;108(9):1400-15; 1416. doi: 10.1038/ajg.2013.218. Epub 2013 Jul 30. Erratum In: Am J Gastroenterol. 2014 Feb;109(2):302.
PMID: 23896955
citation: Bevan MG, Asrani VM, Bharmal S, Wu LM, Windsor JA, Petrov MS. Incidence and predictors of oral feeding intolerance in acute pancreatitis: A systematic review, meta-analysis, and meta-regression. Clin Nutr. 2017 Jun;36(3):722-729. doi: 10.1016/j.clnu.2016.06.006. Epub 2016 Jun 16.
PMID: 27346178
citation: Lodewijkx PJ, Besselink MG, Witteman BJ, Schepers NJ, Gooszen HG, van Santvoort HC, Bakker OJ; Dutch Pancreatitis Study Group. Nutrition in acute pancreatitis: a critical review. Expert Rev Gastroenterol Hepatol. 2016;10(5):571-80. doi: 10.1586/17474124.2016.1141048. Epub 2016 Mar 15.
PMID: 26823272
citation: Jacobson BC, Vander Vliet MB, Hughes MD, Maurer R, McManus K, Banks PA. A prospective, randomized trial of clear liquids versus low-fat solid diet as the initial meal in mild acute pancreatitis. Clin Gastroenterol Hepatol. 2007 Aug;5(8):946-51; quiz 886. doi: 10.1016/j.cgh.2007.04.012. Epub 2007 Jul 5.
PMID: 17613280
citation: Eckerwall GE, Tingstedt BB, Bergenzaun PE, Andersson RG. Immediate oral feeding in patients with mild acute pancreatitis is safe and may accelerate recovery--a randomized clinical study. Clin Nutr. 2007 Dec;26(6):758-63. doi: 10.1016/j.clnu.2007.04.007. Epub 2007 Aug 24.
PMID: 17719703
citation: Li J, Xue GJ, Liu YL, Javed MA, Zhao XL, Wan MH, Chen GY, Altaf K, Huang W, Tang WF. Early oral refeeding wisdom in patients with mild acute pancreatitis. Pancreas. 2013 Jan;42(1):88-91. doi: 10.1097/MPA.0b013e3182575fb5.
PMID: 22836861
citation: Olah A, Romics L Jr. Enteral nutrition in acute pancreatitis: a review of the current evidence. World J Gastroenterol. 2014 Nov 21;20(43):16123-31. doi: 10.3748/wjg.v20.i43.16123.
PMID: 25473164
citation: Petrov MS, van Santvoort HC, Besselink MG, Cirkel GA, Brink MA, Gooszen HG. Oral refeeding after onset of acute pancreatitis: a review of literature. Am J Gastroenterol. 2007 Sep;102(9):2079-84; quiz 2085. doi: 10.1111/j.1572-0241.2007.01357.x. Epub 2007 Jun 16.
PMID: 17573797
citation: Zhao XL, Zhu SF, Xue GJ, Li J, Liu YL, Wan MH, Huang W, Xia Q, Tang WF. Early oral refeeding based on hunger in moderate and severe acute pancreatitis: a prospective controlled, randomized clinical trial. Nutrition. 2015 Jan;31(1):171-5. doi: 10.1016/j.nut.2014.07.002. Epub 2014 Jul 30.
PMID: 25441594
citation: Petrov MS, Pylypchuk RD, Uchugina AF. A systematic review on the timing of artificial nutrition in acute pancreatitis. Br J Nutr. 2009 Mar;101(6):787-93. doi: 10.1017/S0007114508123443. Epub 2008 Nov 19.
PMID: 19017421
citation: Li X, Ma F, Jia K. Early enteral nutrition within 24 hours or between 24 and 72 hours for acute pancreatitis: evidence based on 12 RCTs. Med Sci Monit. 2014 Nov 17;20:2327-35. doi: 10.12659/MSM.892770.
PMID: 25399541
citation: Larino-Noia J, Lindkvist B, Iglesias-Garcia J, Seijo-Rios S, Iglesias-Canle J, Dominguez-Munoz JE. Early and/or immediately full caloric diet versus standard refeeding in mild acute pancreatitis: a randomized open-label trial. Pancreatology. 2014 May-Jun;14(3):167-73. doi: 10.1016/j.pan.2014.02.008. Epub 2014 Mar 14.
PMID: 24854611
responsible party type: Principal Investigator
investigator affiliation: Consorci Sanitari del Garraf
investigator full name: Elena Ramírez-Maldonado
investigator title: Principal investigator
mesh term: Pancreatitis
sharing ipd: Yes
ipd description: The results of this trial will be published in an open access way and disseminates among medical societies
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: From June 2019 the data will be available until publication
ipd access criteria: Open accès publication
provided document: 