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PancreaticoduodenectomyNCT06094465

Learning Curve of Robotic Pancreatoduodenectomy

An observational study of Pancreaticoduodenectomy, run by Peking Union Medical College Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Pancreaticoduodenectomy
What is being tested?
Different phase of the learning curve of RPD
How many people
100 participants
Where
1 siteChina
Study dates
1 Apr 2020to 31 Oct 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: From April 2020 to October 2022, consecutive patients with RPD performed for benign or malignant lesions at Peking Union Medical College Hospital

Who may be able to join

  • patients who received robotic pancreaticoduodenectomy

Who cannot join

  • patients who did not receive robotic pancreaticoduodenectomy

Trial locations and contacts

1 site in 1 country.

China1 site

  • 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

Other trials in China

About this study

Official title: Learning Curve of Robotic Pancreatoduodenectomy for Surgeons With Extensive Laparoscopic Pancreatoduodenectomy Experience

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.

Read the 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.

Being tested
Different phase of the learning curve of RPD
Keywords
robotic pancreaticoduodenctomy, learning curve

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Different phase of the learning curve of RPDOther

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

Study groups in NCT06094465
Study groupRoleWhat they receive
learning phaseAccording to the CUSUM curve, the phase before the peak of the curve is defined as the learning phase.
Receives: Other: Different phase of the learning curve of RPD
proficiency phaseAccording to the CUSUM curve, the phase after the peak of the curve is defined as the learning phase.
Receives: Other: Different phase of the learning curve of RPD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intraoperative operation time

    Intraoperative operation time, defined as the duration from the skin incision to abdominal closure

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

  2. Intraoperative blood loss

    Intraoperative blood loss

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

  3. Conversion to laparotomy

    Conversion to laparotomy

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

  4. Postoperative complications

    Postoperative pancreatic fistula; hemorrhage, abdominal infection, reoperation

    Measured: up to 3 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2023
  2. Study start1 Apr 2020
  3. Primary completion31 Oct 2022
  4. Study completion31 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06094465
Sponsor's protocol ID
RPD
Status last verified
Oct 2023
First submitted
16 Oct 2023
Last updated
23 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30341417

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

    PubMed 7915434

  • 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.

    PubMed 27005287

  • 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.

    PubMed 30973388

  • 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.

    PubMed 33915091

  • 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.

    PubMed 30138162

  • 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.

    PubMed 31602170

  • 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.

    PubMed 33077373

  • 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.

    PubMed 36890417

  • 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.

    PubMed 25761143

Questions about this trial

What is this clinical trial studying?

An observational study of Pancreaticoduodenectomy, run by Peking Union Medical College Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intraoperative operation time (time frame: the data was recorded and collected at the end of the surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06094465, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.

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