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Minimally Invasive Versus Open Distal Pancreatectomy (LEOPARD)

A Multicenter Patient-blinded Randomized Controlled Trial

de Rooij, Thijs MSc*; van Hilst, Jony MD*; van Santvoort, Hjalmar MD, PhD; Boerma, Djamila MD, PhD; van den Boezem, Peter MD, PhD; Daams, Freek MD, PhD§; van Dam, Ronald MD, PhD; Dejong, Cees MD, PhD; van Duyn, Eino MD, PhD||; Dijkgraaf, Marcel PhD**; van Eijck, Casper MD, PhD††; Festen, Sebastiaan MD, PhD‡‡; Gerhards, Michael MD, PhD‡‡; Groot Koerkamp, Bas MD, PhD††; de Hingh, Ignace MD, PhD§§,¶¶; Kazemier, Geert MD, PhD§; Klaase, Joost MD, PhD||; de Kleine, Ruben MD, PhD||||; van Laarhoven, Cornelis MD, PhD; Luyer, Misha MD, PhD§§; Patijn, Gijs MD, PhD***; Steenvoorde, Pascal MD, PhD***; Suker, Mustafa MD††; Abu Hilal, Moh’d MD, PhD†††; Busch, Olivier MD, PhD*; Besselink, Marc MD, PhD* for the Dutch Pancreatic Cancer Group

doi: 10.1097/SLA.0000000000002979

Objective: This trial followed a structured nationwide training program in minimally invasive distal pancreatectomy (MIDP), according to the IDEAL framework for surgical innovation, and aimed to compare time to functional recovery after minimally invasive and open distal pancreatectomy (ODP).

Background: MIDP is increasingly used and may enhance postoperative recovery as compared with ODP, but randomized studies are lacking.

Methods: A multicenter patient-blinded randomized controlled superiority trial was performed in 14 centers between April 2015 and March 2017. Adult patients with left-sided pancreatic tumors confined to the pancreas without vascular involvement were randomly assigned (1:1) to undergo MIDP or ODP. Patients were blinded for type of surgery using a large abdominal dressing. The primary endpoint was time to functional recovery. Analysis was by intention to treat. This trial was registered with the Netherlands Trial Register (NTR5689).

Results: Time to functional recovery was 4 days [interquartile range (IQR) 3–6) in 51 patients after MIDP versus 6 days (IQR 5–8) in 57 patients after ODP (P < 0.001). The conversion rate of MIDP was 8%. Operative blood loss was less after MIDP (150 vs 400 mL; P < 0.001), whereas operative time was longer (217 vs 179 minutes; P = 0.005). The Clavien–Dindo grade ≥III complication rate was 25% versus 38% (P = 0.21). Delayed gastric emptying grade B/C was seen less often after MIDP (6% vs 20%; P = 0.04). Postoperative pancreatic fistulas grade B/C were seen in 39% after MIDP versus 23% after ODP (P = 0.07), without difference in percutaneous catheter drainage (22% vs 20%; P = 0.77). Quality of life (day 3–30) was better after MIDP as compared with ODP, and overall costs were non-significantly less after MIDP. No 90-day mortality was seen after MIDP versus 2% (n = 1) after ODP.

Conclusions: In patients with left-sided pancreatic tumors confined to the pancreas, MIDP reduces time to functional recovery compared with ODP. Although the overall rate of complications was not reduced, MIDP was associated with less delayed gastric emptying and better quality of life without increasing costs.

*Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, the Netherlands

Department of Surgery, St Antonius Hospital, Nieuwegein, and University Medical Center Utrecht, Utrecht, the Netherlands

Department of Surgery, Radboud University Medical Center, Nijmegen, the Netherlands

§Department of Surgery, Cancer Center Amsterdam, VU University Medical Center, Amsterdam, the Netherlands

Department of Surgery, Maastricht University Medical Center, Maastricht, the Netherlands, and Universitätsklinikum Aachen, Aachen, Germany

||Department of Surgery, Medisch Spectrum Twente, Enschede, the Netherlands

**Clinical Research Unit, Amsterdam UMC, University of Amsterdam, the Netherlands

††Department of Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands

‡‡Department of Surgery, OLVG, Amsterdam, the Netherlands

§§Department of Surgery, Catharina Hospital, Eindhoven, the Netherlands

¶¶Department of Surgery, Netherlands Comprehensive Cancer Organisation (IKNL), Utrecht, the Netherlands

||||Department of Surgery, University Medical Center Groningen, Groningen, the Netherlands

***Department of Surgery, Isala Clinics, Zwolle, the Netherlands

†††Department of Surgery, Southampton University Hospital NHS Foundation Trust, Southampton, UK.

Reprints: Marc Besselink, MD, PhD, Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands. E-mail:

TdR and JvH contributed equally to this work.

Funding: A research grant for investigator-initiated studies was received from Ethicon Endo-surgery (Johnson & Johnson Family of Companies, New Brunswick, NJ).

Conflicts of interest: MGB and MAH report receiving consulting and lecturing fees from Ethicon Endo-Surgery (Johnson & Johnson Family of Companies, New Brunswick, NJ). No other potential conflict of interest relevant to this article was reported.

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