Thijs de Rooij1, Jony van Hilst1, Hjalmar van Santvoort2, Djamila Boerma2, Peter van den Boezem3, Freek Daams4, Ronald van Dam5, Cees Dejong5, Eino van Duyn6, Marcel Dijkgraaf7, Casper van Eijck8, Sebastiaan Festen9, Michael Gerhards9, Bas Groot Koerkamp8, Ignace de Hingh10,11, Geert Kazemier4, Joost Klaase6, Ruben de Kleine12, Cornelis van Laarhoven3, Misha Luyer10, Gijs Patijn13, Pascal Steenvoorde13, Mustafa Suker8, Moh'd Abu Hilal14, Olivier Busch1, Marc Besselink1. 1. Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, the Netherlands. 2. Department of Surgery, St Antonius Hospital, Nieuwegein, and University Medical Center Utrecht, Utrecht, the Netherlands. 3. Department of Surgery, Radboud University Medical Center, Nijmegen, the Netherlands. 4. Department of Surgery, Cancer Center Amsterdam, VU University Medical Center, Amsterdam, the Netherlands. 5. Department of Surgery, Maastricht University Medical Center, Maastricht, the Netherlands, and Universitätsklinikum Aachen, Aachen, Germany. 6. Department of Surgery, Medisch Spectrum Twente, Enschede, the Netherlands. 7. Clinical Research Unit, Amsterdam UMC, University of Amsterdam, the Netherlands. 8. Department of Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands. 9. Department of Surgery, OLVG, Amsterdam, the Netherlands. 10. Department of Surgery, Catharina Hospital, Eindhoven, the Netherlands. 11. Department of Surgery, Netherlands Comprehensive Cancer Organisation (IKNL), Utrecht, the Netherlands. 12. Department of Surgery, University Medical Center Groningen, Groningen, the Netherlands. 13. Department of Surgery, Isala Clinics, Zwolle, the Netherlands. 14. Department of Surgery, Southampton University Hospital NHS Foundation Trust, Southampton, UK.
Abstract
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.
RCT Entities:
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.
Authors: Horacio J Asbun; Jony Van Hilst; Levan Tsamalaidze; Yoshikuni Kawaguchi; Dominic Sanford; Lucio Pereira; Marc G Besselink; John A Stauffer Journal: Surg Endosc Date: 2019-05-28 Impact factor: 4.584
Authors: James R Howe; Nipun B Merchant; Claudius Conrad; Xavier M Keutgen; Julie Hallet; Jeffrey A Drebin; Rebecca M Minter; Terry C Lairmore; Jennifer F Tseng; Herbert J Zeh; Steven K Libutti; Gagandeep Singh; Jeffrey E Lee; Thomas A Hope; Michelle K Kim; Yusuf Menda; Thorvardur R Halfdanarson; Jennifer A Chan; Rodney F Pommier Journal: Pancreas Date: 2020-01 Impact factor: 3.327
Authors: Richard S Hoehn; Ibrahim Nassour; Mohamed A Adam; Sharon Winters; Alessandro Paniccia; Amer H Zureikat Journal: J Gastrointest Surg Date: 2020-04-20 Impact factor: 3.452