A Pan-European Study on Minimally Invasive Versus Open Pancreatoduodenectomy in High-volume Centers

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Minimally-invasive pancreatoduodenectomy (MIPD), either laparoscopic or robot-assisted, has been suggested as a valuable alternative to open pancreatoduodenectomy (OPD). The generalizability of the current literature is, however, unknown since randomized studies are lacking, and current data are published from few, very high volume centers and selection bias with a lack of case-matched series. International studies are lacking completely. OBJECTIVE: To compare outcomes of MIPD versus open pancreatoduodenectomy (OPD), in high-volume European pancreas centers (>10 MIPDs per year, total >20 PDs per year). METHODS: A retrospective multicenter propensity-score matched cohort study including all consecutive patients who underwent MIPD (or MI total pancreatectomy) between January 2012 and December 2016, for pancreatic head, bile duct, or duodenal cancer or cysts except chronic pancreatitis. Predefined electronic case report forms will be disseminated amongst participating centers. Participants are responsible for their own data collection. Matching of MIPD cases (collected from participating centers) to OPD controls (extracted from Dutch and German national registries) will be based on propensity scores determined by logistic regression including preoperative variables: year of surgery, demographics, BMI, ASA, comorbidities, tumor size, tumor etiology (diagnosis), and multivisceral resection. Primary outcome is 90-day major morbidity(Clavien-Dindo ≥ 3a). Secondary outcomes are 90-day postoperative events including: pancreatic fistula, length of hospital stay, R0 (microscopically negative) resection margin, malignant lymph node ratio, days to adjuvant therapy and overall survival.

Official Title
-----------------
Outcomes After Minimally Invasive or Open Pancreatoduodenectomy in High-volume Centers; a Pan-European Retrospective Propensity-score Matched Cohort Study

Conditions
-----------------
Pancreas Cyst, Pancreatic Neoplasms, Pancreas Cancer

Intervention / Treatment
-----------------
* Procedure: Minimally invasive pancreatoduodenectomy
* Procedure: Open pancreatoduodenectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for open or minimally invasive pancreatoduodenectomy Pancreatic head, bile duct, or duodenal cancer or cysts Exclusion Criteria: Chronic pancreatitis without suspected solid tumor.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Indication for surgery<br>Solid neoplasms | Procedure: Minimally invasive pancreatoduodenectomy<br>* Laparoscopic, robot-assisted, or hybrid resection<br>Procedure: Open pancreatoduodenectomy<br>* Open resection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major morbidity | Clavien-Dindo grade 3a-5 complications | 90-days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pancreatic fistulae | ISGPS 2017 definition | 90-days | 
| Length of stay | length of hospital stay | 90-days | 
| Radical resection rate | R0/R1/R2 classification | 90-days | 
| Malignant lymph node ratio | Malignant/ non-malignant lymph nodes | 90-days | 
| time to adjuvant therapy | Resection to adjuvant chemo(-radio) therapy | 90-days | 
| Overall survival |  | 90-days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
minimally invasive surgical procedures, pancreas surgery, pancreatoduodenectomy