Learning Curve of Robotic Pancreatoduodenectomy

Pancreaticoduodenectomy Clinical Trial

Official title:

Learning Curve of Robotic Pancreatoduodenectomy for Surgeons With Extensive Laparoscopic Pancreatoduodenectomy Experience

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06094465
• Other study ID #: RPD
• Status: Completed
• Start date: April 1, 2020
• Est. completion date: October 31, 2022

Study information

• Verified date: October 2023
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

patients who received robotic pancreaticoduodenectomy

Exclusion Criteria:

patients who did not receive robotic pancreaticoduodenectomy

Related Conditions & MeSH terms

• Pancreaticoduodenectomy

Intervention

Other:
• Different phase of the learning curve of RPD
Different phases of the learning curve of RPD (learning phase or proficiency phase)

Locations

Country	Name	City	State
China	Department of General Surgery, Peking Union Medical College Hospital (PUMCH), Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (10)

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. — View Citation

Gagner M, Pomp A. Laparoscopic pylorus-preserving pancreatoduodenectomy. Surg Endosc. 1994 May;8(5):408-10. doi: 10.1007/BF00642443. — View 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 — View 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 — View 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; — View 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):73 — View 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. — View 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, Z — View 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. — View 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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative operation time	Intraoperative operation time, defined as the duration from the skin incision to abdominal closure	the data was recorded and collected at the end of the surgery
Primary	Intraoperative blood loss	Intraoperative blood loss	the data was recorded and collected at the end of the surgery
Primary	Conversion to laparotomy	Conversion to laparotomy	The data was recorded and collected at the end of the surgery
Primary	Postoperative complications	Postoperative pancreatic fistula; hemorrhage, abdominal infection, reoperation	up to 3 months after surgery