Benign and premalignant lesions
Conditions
Interventions
Minimally invasive, laparoscopic or robot-assisted, left-sided pancreatectomy
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age at least 18 years; - Indication for elective left-sided pancreatectomy (either only tail, body-tail, neck-body-tail, extended neck-body-tail), either spleen-preserving or non-preserving (because of proven or suspected left-sided benign or premalignant disease); - Both robot-assisted and laparoscopic left-sided pancreatectomy are technically feasible for resection, according to the local treatment team; - Fit to undergo left-sided pancreatectomy according to the surgeon and anaesthesiologist; - Written informed consent.
Exclusion criteria
Exclusion criteria: - Suspected pancreatic ductal adenocarcinoma; - Tumor or cyst larger than 8 cm; - Required resection or ablation of organs other than pancreas and spleen; - Tumor involvement or abutment of major vessels (celiac trunk, mesenteric artery or vena cava); - Pregnancy; - Body mass index >40 kg/m2; - Participation in another study with interference of study outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the COMPOS-panc left score, which combines perioperative and postoperative outcomes into a single, severity-weighted outcome. This score includes the following parameters, measured at 90-days postoperative: unplanned blood transfusion, emergency conversion to open surgery, postoperative pancreatic fistula (POPF), postpancreatectomy hemorrhage (PPH), other complications requiring intervention, multi-organ failure, mortality, length of hospital stay and readmission requiring intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| The most relevant secondary endpoint is total hospital-related costs and includes analyses of the direct cost of the operation, the direct cost of the post-operative hospital period and the total cost of the follow-up period, including readmission, outpatient visits, emergency room visits and reintervention up to 90-days postoperative. Other secondary endpoints are intra-operative outcomes (e.g. type of left-pancreatectomy (LP), blood loss, operative time, conversion, method of pancreatic transection, spleen-preservation rate, Kimura/Warshaw technique, vascular resection, extended resection), postoperative pain, post-operative morbidity (e.g. Clavien-Dindo scores, surgical site infection (SSI), non-surgical complications, pancreatic surgery specific complications according to ISGPS definitions), ideal outcome, health-care resource utilization (e.g. ICU stay), surgeon*s mental and physical strain and quality of life. | — |
Countries
Belgium, Finland, France, Germany, Hungary, Italy, Netherlands, Slovenia, Spain, Sweden, United Kingdom
Contacts
Public ContactC.E. Baggerman van Houweninge
Amsterdam UMC
Outcome results
None listed