An observational study in Pancreaticoduodenectomy, sponsored by Hospital Clínico Universitario de Valladolid. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-11.
Sponsored by Hospital Clínico Universitario de Valladolid · Observational
AIMS: To recruit a large nationwide Spanish series in order to register PF rate and other common morbidity after PD, and to perform external validation of the aforementioned score, as well as to analyze other postoperative blood parameters and biomarkers associated with complications.
METHODS: Observational prospective and multicentric cohort study to perform external validation of the above-mentioned score. All Spanish centers/units performing PD are invited to include participants. Patients will be consecutively recruited during an 8-10 months period, regardless of their annual volume of pancreatic surgery.
Study variables will be hemogram parameters on POD1 and POD2 (specifically lymphocytes), other parameters and biomarkers (RCP, lactate, procalcitonin, amylase, lipase, albumin) and the common variables concerning PD studies.
LIMITATIONS: Heterogeneity in perioperative management and in blood analysis measuring since this is a multicenter study. Possibility of underestimating the PF rate in patients without surgical drainage. Finally, the cases of mini-invasive approach or pancreatogastrostomy will receive a specific subgroup analysis since the score was designed on a series of open PD and pancreatojejunostomy.
BACKGROUND: Complications after pancreatoduodenectomy (PD) are common and pancreatic fistula (PF) is among the most relevant ones. There are few studies analyzing blood parameters determined in the early postoperative period which behave as morbidity predictors. One of them defined a new and simple prognostic score based on lymphocytes count on the first postoperative day (POD1) and reactive C protein (RCP) on POD2. The internal validation statistics of the score designed in the mentioned work were satisfactory. However, that score was described in a short unicentric series
EXPECTED SAMPLE SIZE: Expected sample size is approximately 500 patients, which will show error \<7.2% (with 95% confidence) for estimation score´s sensitivity and specificity. We have assumed that the PF rate is around 30%.
QUALITY CONTROL: The STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) guidelines for the correct communication and publication of observational studies will be followed. Likewise, in order to validate the aforementioned score, Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis (TRIPOD) will be added. The only expected failure of the 20 items that compose the TRIPOD is 6b ("notify the actions for masking the analysis"), since it is not applicable in our case.
The inclusion of patients operated on with a mini-invasive approach (laparoscopic or robotic) or the use of other anastomoses (pancreatogastrostomy) or reconstruction (Roux-en-Y) differs from the technique used in the series with which the score was originally defined (allof them, open PD with pancreato-jejunostomy and, mostly part, tutored ducto-mucosal suture and Child's single loop reconstruction). If discrepancies are detected, the corresponding subgroup analysis will be performed. Cases of conversion from a mini-invasive to open approach will be counted as such (intention-to-treat analysis).
Hospital Clínico Universitario de Valladolid is the lead sponsor of 21 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing PD in Spain
Exclusion Criteria:
All patients undergoing PD during study period in all participating center/units in Spain.
Other: No intervention
Blood analysis
Pancreatic fistula rate
Pancreatic fistula including biochemical, grade B and grade C according to ISGPS updated criteria 2016
Time frame: 90 days since PD
Clinically relevant pancreatic fistula
Pancreatic fistula including grade B and grade C according to ISGPS updated criteria 2016
Time frame: 90 days since PD
Overall complications
Presence of any kind of complications including grades I to V according to Dindo-Clavien Classification
Time frame: 90 days since PD
Severe morbidity
Presence of any kind of complications including grades IIIa to V according to Dindo-Clavien Classification
Time frame: 90 days since PD
Mortality
Patient´s death
Time frame: 90 days since PD
Comprehensive Complication Index
Postoperative morbidity index (0-100 points) obteined by using formula described by Slankamenac et al Ann Surg 2013
Time frame: 90 days since PD
Plan to share: Undecided
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Hospital Clínico Universitario de Valladolid