Pancreatic Neoplasms Clinical Trial
— PSMLOPDOfficial title:
Morbidity and Survival After Minimally Invasive Versus Open Pancreatoduodenectomy: Propensity Score Matched Comparison
Verified date | October 2021 |
Source | General Hospital Groeninge |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 172 |
Est. completion date | March 20, 2021 |
Est. primary completion date | January 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - diagnosis of lesion of pancreatic head or peri-ampullary organs Exclusion Criteria: - < 18 years old |
Country | Name | City | State |
---|---|---|---|
Belgium | General Hospital Groeninge | Kortrijk |
Lead Sponsor | Collaborator |
---|---|
General Hospital Groeninge |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Major complication rate | Complications classified as morbidity classification 3a or greater (Clavien-Dindo) | 90 days postoperative | |
Secondary | Perioperative outcomes | Operative time (min), blood transfusion requirements, estimated blood loss (mL) | Up to 30 days | |
Secondary | Short-term postoperative outcomes | Hospital stay (days), drain in situ (days), ICU stay (days) | Up to 30 days | |
Secondary | Postoperative morbidity | All complications classified as morbidity classification 3a or greater (Clavien-Dindo) | 90 days | |
Secondary | Pancreatectomy-specific complications | Postoperative pancreatic fistula, Post-pancreatectomy haemorrhage, delayed gastric emptying, as defined by the respective ISGPS classification | 90 days | |
Secondary | 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 | |
Secondary | 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 |
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