Pancreatitis Clinical Trial
Official title:
Non-inferiority Comparative Clinical Trial Between Early Oral Refeeding Versus Usual Oral Refeeding in Mild Acute Pancreatitis Patients
Background The aim of the study is to compare the onset of oral feeding in the first 24 hours after hospital admission and determine if this influences the recurrence of pain or alters the blood levels of pancreatic enzymes, compared to usual oral refeeding in patients with mild acute pancreatitis Methods This Non-Inferiority Randomized controlled trial was carried out between September 2018 and June 2019, prior authorization from the ethics committee in health research. Patients with diagnosis of mild acute biliary pancreatitis, were divided into: Group A (early oral refeeding) and Group B (usual oral refeeding). Outcome measures were lipase pancreatic, systemic inflammatory response (concentrations of leukocytes) were used as marker for it, feasibility evaluated by abdominal pain recurrence, presence and recurrence of gastrointestinal symptoms and length of hospital stay. The aim of the present study is to compare the onset of oral feeding in the first 24 hours after hospital admission and determine if this influences the recurrence of pain or alters the blood levels of pancreatic enzymes, compared to usual oral refeeding in patients with mild acute pancreatitis.
BACKGROUND Acute pancreatitis (AP) is an inflammatory pancreatic process, presents different
severity degrees [1]. Over the last two decades, there has been a paradigm shift in the
management, from surgical to "step up" approach using percutaneous or endoscopic catheter
drainage followed by minimally invasive necrosectomy [2]. As no curative therapy is currently
available for AP, early treatment consists of supportive care which includes adequate fluid
resuscitation, pain management and enteral nutrition [3]. Pancreatic rest by Nil Per Oral
(NPO) strategy was considered necessary in AP till abdominal pain get resolved and the levels
of pancreatic and inflammatory markers decrease [4]. This trend has changed, now it is clear
that the early oral refeeding for PA mild does not only provide adequate caloric intake, it
may also improve clinical outcomes. It has been hypothesized that the combination of
disturbed intestinal motility, microbial overgrowth and increased permeability of the gut can
lead to bacterial translocation, thus causing infection of pancreatic necrosis [5,6].
The oral refeeding (OR) may reduce translocation by stimulating intestinal motility, reducing
bacterial overgrowth and thereby maintaining mucosal gut integrity [7,8]. Also decrease
infection complications, organ failure and mortality as compared with routine total
parenteral nutrition [9,10]. In patients with (predicted) mild pancreatitis, numerous studies
concluded that a normal oral diet can be resumed once the pain is decreasing [11-13],
However, it remains unclear what the optimal time to do it is. There is still no consensus
about the definition of "early" refeeding.
The aim of the present study is to compare the onset of oral feeding in the first 24 hours
after hospital admission and determine if this influences the recurrence of pain or alters
the blood levels of pancreatic enzymes, compared to usual oral refeeding in patients with
mild acute pancreatitis.
METHODS
Patients This Randomized controlled trial was carried out between September 2018 and June
2019, prior authorization from the ethics committee in health research.
A total number of 124 patients were randomized in this study. The sample size was calculated
according to the formula published by Bouemn et all 2015 [14], in which a percentage of
success was estimated with the standard treatment of 90% compared to the experimental
management of 85%, with a margin of no less than 10%, with an alpha for a tail of 0.05%, and
a beta of 20 %, with a percentage of estimated losses of approximately 10%, a total of 62
patients per group was obtained.
Definitions The diagnosis of AP was established when the patient presents two or more of the
following three findings: typical abdominal pain, elevation of serum pancreatic enzymes
(amylase and/or lipase) at more than three times the upper limit of the normal value, and
imaging study (ultrasonography or computed tomography) suggestive of AP [15].
Severity Assessment Severity assessment of AP was done based on the revised Atlanta
classification into mild, moderately severe and severe. Absence of organ failure or local or
systemic complications was labelled as mild AP; of was defined using the modified Marshall
scoring system [16]; and only the patients whose complete these severity criteria were
randomized for the study.
Protocol Once the diagnosis of acute biliary pancreatitis was confirmed and the course was
mild, corresponding informed consent signed.
Fluid therapy with crystalloid solution (Hartmann), initial bolus of 10 mL / kg and followed
by infusion for 24 h of 1.5 mL / kg / h.
Pain management with opioid weak tramadol 50mg every 6 hours and paracetamol 1 gram every 8
hours with continuous evaluation of the analogue numerical scale to determine the need for
extra doses
Type of Diet:
In both groups, their initial diet was the same so that this did not influence the results to
be measured.
The soft diet consisted of one of 900 Kcal per day, with 86.7% carbohydrates (190 g), 13.3%
protein (30 g) and 0% lipids (0 g); during 24 h.
When the diet was adequately tolerated and there was no evidence of clinical complications or
deterioration, normal diet was indicated, and the follow-up continues.
Data Collection:
Laboratorial data, such as leukocytes, amylase and lipase were collected after inclusion in
the study and after 24 and 48 h of oral refeeding. Clinical data records include age, gender,
time from onset of pain baseline, Marshall score at admission and after start the oral
feeding, gastrointestinal symptoms, abdominal pain, days until solid food intake, pain
relapse, complications, length of hospital stay and readmissions.
Statistical analysis Date are presented as frequency and percentage, comparisons between
groups were using the χ2 test for binary data or Fisher´s exact test. Continuous variables
are presented as median and range interquartile range and were compared using the
Mann-Whitney U-test or t student test if they meet normal criteria. p-Values of less than
0.05 were considered significant. Statistical analyses were performed with SPSS version
25.0.0. Analysis by intention to treat was used.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03609944 -
SpHincterotomy for Acute Recurrent Pancreatitis
|
N/A | |
Not yet recruiting |
NCT04652271 -
International Pancreatic Surgery Outcomes Study - PancreasGroup.Org
|
||
Completed |
NCT01441492 -
Pancreas Resection With and Without Drains
|
N/A | |
Recruiting |
NCT02196935 -
Los Angeles Prospective GI Biliary and EUS Series
|
||
Completed |
NCT01476995 -
Prognostic Indicators as Provided by the EPIC ClearView
|
N/A | |
Completed |
NCT01545167 -
The North American Pancreatitis Study
|
N/A | |
Recruiting |
NCT03334708 -
A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma
|
||
Completed |
NCT01824186 -
Trial Comparing Pain in Single-incision Laparoscopic Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy
|
N/A | |
Terminated |
NCT00428025 -
Diclofenac for the Prevention of Post-ERCP Pancreatitis in Higher Risk Patients
|
Phase 4 | |
Completed |
NCT00639314 -
Trial on the Evaluation of Pylorus-ring in Pancreaticoduodenectomy
|
N/A | |
Recruiting |
NCT00160836 -
Biliary Tissue Sampling Using a Cytology Brush or the GIUM Catheter
|
Phase 1 | |
Completed |
NCT00121901 -
Does Glyceryl Nitrate Prevent Post-Endoscopic Retrograde Cholangiopancreaticography (ERCP) Pancreatitis?
|
Phase 3 | |
Completed |
NCT00999232 -
Assess the Effect of Erythromycin on the Rate of Success in Placement of a Self-propelled Feeding Tube
|
Phase 4 | |
Terminated |
NCT00419549 -
Efficacy Study of Glyceryl-Trinitrate Patch and Parecoxib (Valdecoxib) for the Prevention of Pancreatitis After Endoscopic Retrograde Cholangiopancreatography (ERCP)
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT05095831 -
EUS Shear Wave for Solid Pancreatic Lesions.
|
||
Completed |
NCT03601325 -
Acute Pancreatitis: Study of Possible Etiologies and Risk Factors Affecting Outcome
|
||
Not yet recruiting |
NCT06133023 -
WONDER-02 Trial: Plastic Stent vs. Lumen-apposing Metal Stent for Pancreatic Pseudocysts
|
N/A | |
Withdrawn |
NCT02465138 -
A Randomized Controlled Trial of IV Ketorolac to Prevent Post-ERCP Pancreatitis
|
Phase 4 | |
Recruiting |
NCT02971475 -
ESWL Versus ESWL and Endoscopic Treatment
|
N/A | |
Recruiting |
NCT02305914 -
Follow-up Study of Complications of Acute Pancreatitis
|
N/A |