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

Rationale: 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.

Postoperative 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.

All major/minor open or laparoscopic hepatopancreatobiliary surgery (excluding diagnostic laparoscopy).