Clinical trial · Observational
A Pan-European Study on Minimally Invasive Versus Open Pancreatoduodenectomy in High-volume Centers
Outcomes After Minimally Invasive or Open Pancreatoduodenectomy in High-volume Centers; a Pan-European Retrospective Propensity-score Matched Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
| Pancreas Cyst | — | UNRESOLVED | — |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Minimally invasive pancreatoduodenectomy | Procedure | — | UNRESOLVED |
| Open pancreatoduodenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Indication for surgery
- description
- Solid neoplasms
- interventionNames
- Procedure: Minimally invasive pancreatoduodenectomy
- Procedure: Open pancreatoduodenectomy
Primary outcomes (1)
- measure
- Major morbidity
- timeFrame
- 90-days
- description
- Clavien-Dindo grade 3a-5 complications
Secondary outcomes (6)
- measure
- Pancreatic fistulae
- timeFrame
- 90-days
- description
- ISGPS 2017 definition
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDKlompmaker S, van Hilst J, Wellner UF, Busch OR, Coratti A, D'Hondt M, Dokmak S, Festen S, Kerem M, Khatkov I, Lips DJ, Lombardo C, Luyer M, Manzoni A, Molenaar IQ, Rosso E, Saint-Marc O, Vansteenkiste F, Wittel UA, Bonsing B, Groot Koerkamp B, Abu Hilal M, Fuks D, Poves I, Keck T, Boggi U, Besselink MG; European consortium on Minimally Invasive Pancreatic Surgery (E-MIPS). Outcomes After Minimally-invasive Versus Open Pancreatoduodenectomy: A Pan-European Propensity Score Matched Study. Ann Surg. 2020 Feb;271(2):356-363. doi: 10.1097/SLA.0000000000002850. PMID 29864089