Clinical trial NCT06094465: Learning Curve of Robotic Pancreatoduodenectomy
Official title: Learning Curve of Robotic Pancreatoduodenectomy for Surgeons With Extensive Laparoscopic Pancreatoduodenectomy Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreaticoduodenectomy
Keywords: robotic pancreaticoduodenctomy
learning curve
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From April 2020 to October 2022, consecutive patients with RPD performed for benign or malignant lesions at Peking Union Medical College Hospital

Brief summary: A few reports were focused on the RPD learning curve for surgeons with extensive experience in LPD. Therefore, this study aimed to investigate the number of cases required for such surgeons to overcome the learning curve for RPD and to analyze the impact of different phases of the learning curve on perioperative outcomes.

Detailed description: With the development of robotic surgery systems, their unique advantages over traditional laparoscopic surgery systems, such as a three-dimensional 10-fold magnified view, seven degrees of freedom for flexible wrist movements, tremor filtering, and good ergonomic design, have significantly improved the precision and quality of surgery. The literature has reported that, compared with the laparoscopic surgery system, the robotic surgery system can reduce intraoperative blood loss and the conversion rate to laparotomy, in addition to the dissection of more lymph nodes. Therefore, robotic surgery has become increasingly popular. As the economy develops and surgeons gain more experience in LPD, many are shifting their focus to robotic pancreatoduodenectomy after mastering laparoscopic techniques. There are a few reports on the RPD learning curve for surgeons with extensive experience in LPD. Therefore, this study aimed to investigate the number of cases required for such surgeons to overcome the learning curve for RPD and to analyze the impact of different phases of the learning curve on perioperative outcomes.

Eligibility criteria: Inclusion Criteria:

patients who received robotic pancreaticoduodenectomy

Exclusion Criteria:

patients who did not receive robotic pancreaticoduodenectomy

Primary outcomes:
measure: Intraoperative operation time
timeFrame: the data was recorded and collected at the end of the surgery
measure: Intraoperative blood loss
timeFrame: the data was recorded and collected at the end of the surgery
measure: Conversion to laparotomy
timeFrame: The data was recorded and collected at the end of the surgery
measure: Postoperative complications
timeFrame: up to 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of General Surgery, Peking Union Medical College Hospital (PUMCH), Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Menghua Dai, MD
role: STUDY_CHAIR
References:
citation: Strobel O, Neoptolemos J, Jager D, Buchler MW. Optimizing the outcomes of pancreatic cancer surgery. Nat Rev Clin Oncol. 2019 Jan;16(1):11-26. doi: 10.1038/s41571-018-0112-1.
citation: Gagner M, Pomp A. Laparoscopic pylorus-preserving pancreatoduodenectomy. Surg Endosc. 1994 May;8(5):408-10. doi: 10.1007/BF00642443.
citation: Zhang H, Wu X, Zhu F, Shen M, Tian R, Shi C, Wang X, Xiao G, Guo X, Wang M, Qin R. Systematic review and meta-analysis of minimally invasive versus open approach for pancreaticoduodenectomy. Surg Endosc. 2016 Dec;30(12):5173-5184. doi: 10.1007/s00464-016-4864-3. Epub 2016 Mar 22.
citation: Nickel F, Haney CM, Kowalewski KF, Probst P, Limen EF, Kalkum E, Diener MK, Strobel O, Muller-Stich BP, Hackert T. Laparoscopic Versus Open Pancreaticoduodenectomy: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Ann Surg. 2020 Jan;271(1):54-66. doi: 10.1097/SLA.0000000000003309.
citation: Wang M, Li D, Chen R, Huang X, Li J, Liu Y, Liu J, Cheng W, Chen X, Zhao W, Li J, Tan Z, Huang H, Li D, Zhu F, Qin T, Ma J, Yu G, Zhou B, Zheng S, Tang Y, Han W, Meng L, Ke J, Feng F, Chen B, Yin X, Chen W, Ma H, Xu J, Liu Y, Lin R, Dong Y, Yu Y, Liu J, Zhang H, Qin R; Minimally Invasive Treatment Group in the Pancreatic Disease Branch of China's International Exchange and Promotion Association for Medicine and Healthcare (MITG-P-CPAM). Laparoscopic versus open pancreatoduodenectomy for pancreatic or periampullary tumours: a multicentre, open-label, randomised controlled trial. Lancet Gastroenterol Hepatol. 2021 Jun;6(6):438-447. doi: 10.1016/S2468-1253(21)00054-6. Epub 2021 Apr 27.
citation: Poves I, Burdio F, Morato O, Iglesias M, Radosevic A, Ilzarbe L, Visa L, Grande L. Comparison of Perioperative Outcomes Between Laparoscopic and Open Approach for Pancreatoduodenectomy: The PADULAP Randomized Controlled Trial. Ann Surg. 2018 Nov;268(5):731-739. doi: 10.1097/SLA.0000000000002893.
citation: Zhang H, Lan X, Peng B, Li B. Is total laparoscopic pancreaticoduodenectomy superior to open procedure? A meta-analysis. World J Gastroenterol. 2019 Oct 7;25(37):5711-5731. doi: 10.3748/wjg.v25.i37.5711.
citation: Kamarajah SK, Gujjuri R, Bundred JR, Hilal MA, White SA. Long-term survival after minimally invasive resection versus open pancreaticoduodenectomy for periampullary cancers: a systematic review, meta-analysis and meta-regression. HPB (Oxford). 2021 Feb;23(2):197-205. doi: 10.1016/j.hpb.2020.09.023. Epub 2020 Oct 16.
citation: Kawka M, Gall TMH, Hand F, Nazarian S, Cunningham D, Nicol D, Jiao LR. The influence of procedural volume on short-term outcomes for robotic pancreatoduodenectomy-a cohort study and a learning curve analysis. Surg Endosc. 2023 Jun;37(6):4719-4727. doi: 10.1007/s00464-023-09941-8. Epub 2023 Mar 8.
citation: Boone BA, Zenati M, Hogg ME, Steve J, Moser AJ, Bartlett DL, Zeh HJ, Zureikat AH. Assessment of quality outcomes for robotic pancreaticoduodenectomy: identification of the learning curve. JAMA Surg. 2015 May;150(5):416-22. doi: 10.1001/jamasurg.2015.17.