Single-centre Propensity Score-matched Comparison of Laparoscopic Versus Open Pancreatoduodenectomy

Study Overview
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Brief Summary
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Minimally invasive pancreatoduodenectomy is increasingly performed. However, technical challenges and a perceived higher risk of complications has hindered wide adoption of a minimally invasive approach. This is a retrospective comparison of a prospectively kept database. The investigators compared surgical outcomes and survival after laparoscopic (LPD) versus open pancreatoduodenectomy (OPD). In order to reduce the effect of bias and confounding, baseline characteristics of both groups were matched using propensity score matching.

Detailed Description
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All pancreatoduodenectomies were retrieved from a prospectively kept database and retrospectively analysed. All procedures were performed in a single supra-regional Belgian centre. The primary endpoint was the major complication rate, defined by a Clavien-Dindo morbidity classification grade IIIa or higher [11]. Secondary endpoints were 90-day mortality rate, length of hospital stay, operative time, blood loss, transfusion requirements and specific pancreatic complications (pancreatic fistula, haemorrhage, and delayed gastric emptying). In addition, overall survival (OS) and disease-free survival (DFS) were analysed in the subgroups of cancer patients.

Official Title
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Morbidity and Survival After Minimally Invasive Versus Open Pancreatoduodenectomy: Propensity Score Matched Comparison

Conditions
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Pancreatic Neoplasms

Intervention / Treatment
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* Procedure: pancreatoduodenectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of lesion of pancreatic head or peri-ampullary organs Exclusion Criteria: < 18 years old

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Laparoscopic pancreatoduodenectomy<br>Cohort of patients that underwent a Whipple-procedure through a laparoscopic approach. | Procedure: pancreatoduodenectomy<br>* Patients included in the cohorts all underwent pancreatoduodenectomy, open or laparoscopic<br>|
| Open pancreatoduodenectomy<br>Cohort of patients that underwent a Whipple-procedure through a traditional open approach. | Procedure: pancreatoduodenectomy<br>* Patients included in the cohorts all underwent pancreatoduodenectomy, open or laparoscopic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major complication rate | Complications classified as morbidity classification 3a or greater (Clavien-Dindo) | 90 days postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative outcomes | Operative time (min), blood transfusion requirements, estimated blood loss (mL) | Up to 30 days | 
| Short-term postoperative outcomes | Hospital stay (days), drain in situ (days), ICU stay (days) | Up to 30 days | 
| Postoperative morbidity | All complications classified as morbidity classification 3a or greater (Clavien-Dindo) | 90 days | 
| Pancreatectomy-specific complications | Postoperative pancreatic fistula, Post-pancreatectomy haemorrhage, delayed gastric emptying, as defined by the respective ISGPS classification | 90 days | 
| Overall survival and disease-free survival | The Kaplan-Meier method was used for estimation of survival and compared between subgroups of cancer patients | Up to 20 years | 
| Oncological outcomes | Analysis of resection specimen following contemporary pathlogy guidelines and defined by TNM staging system of pancreatic cancer by AJCC/UICC. | Up to 20 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreatoduodenectomy, minimally-invasive surgery, pancreatic cancer, chronic pancreatitis