Minimally invasive pancreatoduodenectomy is as safe as open pancreatoduodenectomy
ID
Bron
Verkorte titel
Aandoening
Pancreatic and peri-ampullary disease
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Safety parameters and IL-6 serum levels
Achtergrond van het onderzoek
Inclusion of phase 2 is completed on 20-12-2016, the data safety monitoring board allowed the start of phase 3 on 29-01-2017. Primary outcome of phase 3 is time to functional recovery. Patients included in phase 2 are also included in phase 3. Inclusion and exclusion criteria for phase 2 and phase 3 are equal. Target number of patients is 136 (94 additional patients) and planned closingdate is 29-01-2018.
Doel van het onderzoek
Minimally invasive pancreatoduodenectomy is as safe as open pancreatoduodenectomy
Onderzoeksopzet
- Baseline
- Operation
- 2 weeks postoperatively
- 1 month postoperatively
- 3 months postoperatively
Onderzoeksproduct en/of interventie
- Minimally invasive pancreatoduodenectomy
- Open pancreatoduodenectomy
Publiek
Thijs
de Rooij
PB 22660
1105 AZ
+31 20 566 2661
t.derooij@amc.nl
Wetenschappelijk
Thijs
de Rooij
PB 22660
1105 AZ
+31 20 566 2661
t.derooij@amc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Age equal or above 18 years
- Indication for elective pancreatoduodenectomy because of a malignant, pre-malignant or symptomatic benign disease located in the pancreatic head, distal bile duct, duodenum or ampulla of Vater
- The procedure can be performed both minimally invasive and open according to the local surgeon
- Fit to undergo pancreatoduodenectomy according to the surgeon and anaesthetist
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- A second cancer requiring resection during the same procedure
- Administration of neo-adjuvant radiotherapy
- Vascular involvement (portal vein, superior mesenteric vein, superior mesenteric artery or hepatic artery)
- Pregnancy
- Body mass index >35 kg/m2
- Participation in another study with interference of study outcomes
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5556 |
| NTR-old | NTR5689 |
| CCMO | NL54453.018.15 |
| OMON | NL-OMON44749 |