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Preoperative risk stratification in liver and pancreas surgery: comparing predictive risk model with the judgment of the surgeon


- candidate number18158
- NTR NumberNTR4649
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-jun-2014
- Secondary IDs14-325 METC UMC Utrecht
- Public TitlePreoperative risk stratification in liver and pancreas surgery: comparing predictive risk model with the judgment of the surgeon
- Scientific TitlePreoperative risk stratification in open and laparoscopic hepato-pancreato-biliary surgery: comparing predictive risk models with the clinical judgment of the surgeon: External Validation of the RISC study
- ACRONYMThe RISC study
- hypothesis
- Healt Condition(s) or Problem(s) studiedLiver, Bile ducts, Pancreas, Surgery
- Inclusion criteriaPatients undergoing abdominal surgery for possible malignancy or benign lesions in the pancreas, liver or bile ducts.
- Exclusion criteria1. Patients younger than 18 years
2. Adults lacking capacity
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupCrossover
- TypeSingle arm
- Studytypeobservational
- planned startdate 20-jun-2014
- planned closingdate20-jun-2016
- Target number of participants289
- InterventionsAll major/minor open or laparoscopic hepatopancreatobiliary surgery (excluding diagnostic laparoscopy).
- Primary outcomeTo assess whether the available predictive risk models are superior compared to the clinical judgment of the consultants (surgeons risk assessment) as regards to predicting the risk of postoperative complications and mortality.
- Secondary outcomeAssessment of the inter-observer variability of the surgeon risk assessment.
- TimepointsPostoperative complications are defined as complications that require surgical, endoscopical or radiological intervention or complications with single/multi organ dysfunction(Clavien Dindo classification grade III/IV)

Operative mortality is defined as in-hospital death (irrespective of the duration of stay) or death occurring within 30 days after discharge.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMiss M. Samim
- CONTACT for SCIENTIFIC QUERIESMD PhD Marc G.H. Besselink
- Sponsor/Initiator University Medical Center Utrecht (UMCU), Department of Surgery
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU), Department of Surgery
- Publications
- Brief summaryRationale: The number of patients who are referred to surgery for treatment of (pre) malignant or benign hepatopancreatobiliary (HPB) disease is increasing. This is due to improved surgical techniques and advances in abdominal surgery. Another explanation for the increasing HPB surgery workload is the implementation of centralization to tertiary centres and acceptance of major abdominal surgery as a safe modality in the elderly. Despite the increased experience and advances in HPB surgery, it is still considered high-risk and is often accompanied by low- or high-grade postoperative complications. Furthermore, most of these patients have comorbidities that in turn increase the risk of postoperative complications.

Objectives: The primary objective is to assess whether the available risk score models are superior compared to the clinical judgment of the operating surgeon with regard to predicting the risk of postoperative outcome (morbidity and mortality). Secondary objective is assessment of the inter-observer variability of the consultants risk assessment.

Study design: Prospective observational multicenter study

Study population: Patients > 18 years, who are eligible for open or laparoscopic hepatopancreatobiliary surgery (including all surgical procedures of liver, gallbladder, bile ducts and pancreas; excluding diagnostic laparoscopy)

Intervention: There are no experimental interventions.

Main study parameters/endpoints: The main primary study parameters are the surgical risk assessment, the postoperative complication rate and the postoperative mortality. The postoperative morbidity will be evaluated according to the Clavien-Dindo classification for postoperative complications. Secondary study parameter is the surgical related mortality.
- Main changes (audit trail)
- RECORD18-jun-2014 - 29-jul-2014


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