NCT06094465

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

2.6 years

First QC Date

October 16, 2023

Last Update Submit

October 19, 2023

Conditions

Pancreaticoduodenectomy

Keywords

robotic pancreaticoduodenctomylearning curve

Outcome Measures

Primary Outcomes (4)

  • 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

  • Intraoperative blood loss

    Intraoperative blood loss

    the data was recorded and collected at the end of the surgery

  • Conversion to laparotomy

    Conversion to laparotomy

    The data was recorded and collected at the end of the surgery

  • Postoperative complications

    Postoperative pancreatic fistula; hemorrhage, abdominal infection, reoperation

    up to 3 months after surgery

Study Arms (2)

learning phase

According to the CUSUM curve, the phase before the peak of the curve is defined as the learning phase.

Other: Different phase of the learning curve of RPD

proficiency phase

According to the CUSUM curve, the phase after the peak of the curve is defined as the learning phase.

Other: Different phase of the learning curve of RPD

Interventions

Different phase of the learning curve of RPDOTHER

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

learning phaseproficiency phase

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • patients who received robotic pancreaticoduodenectomy

You may not qualify if:

  • patients who did not receive robotic pancreaticoduodenectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (10)

  • 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.

    PMID: 30341417RESULT

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

    PMID: 7915434RESULT

  • 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.

    PMID: 27005287RESULT

  • 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.

    PMID: 30973388RESULT

  • 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.

    PMID: 33915091RESULT

  • 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.

    PMID: 30138162RESULT

  • 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.

    PMID: 31602170RESULT

  • 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.

    PMID: 33077373RESULT

  • 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.

    PMID: 36890417RESULT

  • 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.

    PMID: 25761143RESULT

Study Officials

  • Menghua Dai, MD

    Peking Union Medical College Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2023

First Posted

October 23, 2023

Study Start

April 1, 2020

Primary Completion

October 31, 2022

Study Completion

October 31, 2022

Last Updated

October 23, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)