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Gastric CancerNCT06811753

Impact of Robotic Surgery on Systemic Immune-inflammation Index

An observational study of Gastric Cancer, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).

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

Robotic surgery has been gaining attention because of the physical and metabolic morbidity of the conventional open technique.The systemic immune-inflammation index(SII) has emerged as a recent and more reliable biomarker.In our single-center retrospective cohort study, the investigators investigate SII in robotic… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer
What is being tested?
robotic surgery
Type of treatment
Surgery or procedure
How many people
300 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2023to 1 Jan 2025
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: patients operated for gastric cancer

Who may be able to join

  • gastric cancer patients treated with surgery

Who cannot join

  • patients with haematologic malignancy, immune system disorder, antiplatelet drug usage, operations including splenectomy

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Basaksehir Cam and Sakura City Hospital

    Istanbul, Basakşehir, 212

Other trials in Turkey (Türkiye)

About this study

Official title: Impact of Robotic Surgery on Systemic Immune-inflammation Index in Gastric Cancer Patients

Robotic surgery has been gaining attention because of the physical and metabolic morbidity of the conventional open technique.The systemic immune-inflammation index(SII) has emerged as a recent and more reliable biomarker.In our single-center retrospective cohort study, the investigators investigate SII in robotic gastrectomy in order to show the advantageous effect on immune system which the investigators think as the first study in the literature.

Read the detailed description

Patients who underwent robotic gastrectomy between January 2021 and September 2024 were included in the study. The primary outcome was to ascertain the beneficial effects of robotic surgery in gastric cancer patients in terms of immune response. The secondary outcome was to examine the reliability of SII as a serum biomarker in comparison to previous studies on the diagnosis and postoperative follow-up of gastric cancer.

Conditions
Gastric Cancer
Being tested
robotic surgery
Keywords
gastric cancer, minimally invasive gastrectomy, systemic immune-inflammation index, Robotic surgery
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • robotic surgeryProcedure or surgery

    minimally invasive surgery

Study groups in NCT06811753
Study groupRoleWhat they receive
Group 1robotic surgery
Receives: Procedure: robotic surgery
Group 2laparoscopic surgery
Group 3open surgery

What is being measured

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

  1. Systemic inflammatory index

    Systemic inflammatory index (SII= (platelet count x neutrophil count)/lymphocyte count) was predicted to be lower in patients undergoing minimally invasive surgery. The neutrophil-lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLT) have been the subject of investigation as potential biomarkers to show the immune response to the surgical procedure.

    Measured: One year

Timeline

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

  1. First posted6 Feb 2025
  2. Study start1 Dec 2023
  3. Primary completion31 Dec 2024
  4. Study completion1 Jan 2025

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
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06811753
Sponsor's protocol ID
BasaksehirCamveSakura 2024-52
Status last verified
Jan 2025
First submitted
27 Jan 2025
Last updated
6 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: demographics, surgery type, blood counts

Publications

  • Lin GS, Huang XY, Lu J, Wu D, Zheng HL, Xu BB, Zheng CH, Li P, Xie JW, Wang JB, Lin JX, Chen QY, Cao LL, Lin M, Tu RH, Lin GT, Huang ZN, Lin JL, Huang CM. A good preoperative immune prognostic index is predictive of better long-term outcomes after laparoscopic gastrectomy compared with open gastrectomy for stage II gastric cancer in elderly patients. Surg Endosc. 2022 Mar;36(3):1814-1826. doi: 10.1007/s00464-021-08461-7. Epub 2021 Jun 2.

    PubMed 34076769

  • Zhu RH, Li PC, Zhang J, Song HH. Impact of minimally invasive surgery on immune function and stress response in gastric cancer patients. World J Gastrointest Surg. 2024 Aug 27;16(8):2484-2493. doi: 10.4240/wjgs.v16.i8.2484.

    PubMed 39220065

  • Aziz MH, Sideras K, Aziz NA, Mauff K, Haen R, Roos D, Saida L, Suker M, van der Harst E, Mieog JS, Bonsing BA, Klaver Y, Koerkamp BG, van Eijck CH. The Systemic-immune-inflammation Index Independently Predicts Survival and Recurrence in Resectable Pancreatic Cancer and its Prognostic Value Depends on Bilirubin Levels: A Retrospective Multicenter Cohort Study. Ann Surg. 2019 Jul;270(1):139-146. doi: 10.1097/SLA.0000000000002660.

    PubMed 29334554

  • Hirahara N, Matsubara T, Fujii Y, Kaji S, Kawabata Y, Hyakudomi R, Yamamoto T, Taniura T, Tajima Y. Comparison of the prognostic value of immunoinflammation-based biomarkers in patients with gastric cancer. Oncotarget. 2020 Jul 7;11(27):2625-2635. doi: 10.18632/oncotarget.27653. eCollection 2020 Jul 7.

    PubMed 32676164

  • Margraf A, Ludwig N, Zarbock A, Rossaint J. Systemic Inflammatory Response Syndrome After Surgery: Mechanisms and Protection. Anesth Analg. 2020 Dec;131(6):1693-1707. doi: 10.1213/ANE.0000000000005175.

    PubMed 33186158

  • Kinoshita T, Sato R, Akimoto E, Tanaka Y, Okayama T, Habu T. Reduction in postoperative complications by robotic surgery: a case-control study of robotic versus conventional laparoscopic surgery for gastric cancer. Surg Endosc. 2022 Mar;36(3):1989-1998. doi: 10.1007/s00464-021-08483-1. Epub 2021 Apr 12.

    PubMed 33844086

  • Nagata H, Kinoshita T, Komatsu M, Habu T, Yoshida M, Yura M. Comparison of robotic versus laparoscopic total gastrectomy for gastric cancer: A single-center retrospective cohort study in a Japanese high-volume center. Eur J Surg Oncol. 2024 Dec;50(12):108706. doi: 10.1016/j.ejso.2024.108706. Epub 2024 Sep 28.

    PubMed 39357414

Questions about this trial

What is this clinical trial studying?

An observational study of Gastric Cancer, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).

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 6 Feb 2025. 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 Turkey (Türkiye). 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?

Systemic inflammatory index (time frame: One year). 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 NCT06811753, which also lists 7 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 6 Feb 2025.

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