- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06811753
Impact of Robotic Surgery on Systemic Immune-inflammation Index
January 31, 2025 updated by: Başakşehir Çam & Sakura City Hospital
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.
Study Overview
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.
Study Type
Observational
Enrollment (Actual)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Basakşehir
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İstanbul, Basakşehir, Turkey, 212
- Basaksehir Cam and Sakura City Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
patients operated for gastric cancer
Description
Inclusion Criteria:
gastric cancer patients treated with surgery
Exclusion Criteria:
patients with haematologic malignancy, immune system disorder, antiplatelet drug usage, operations including splenectomy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group 1
robotic surgery
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minimally invasive surgery
|
|
Group 2
laparoscopic surgery
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|
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Group 3
open surgery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Systemic inflammatory index
Time Frame: One year
|
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.
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yiğit Düzköylü, assoc. prof., Başakşehir Çam & Sakura City Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2023
Primary Completion (Actual)
December 31, 2024
Study Completion (Actual)
January 1, 2025
Study Registration Dates
First Submitted
January 27, 2025
First Submitted That Met QC Criteria
January 31, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 31, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BasaksehirCamveSakura 2024-52
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
demographics, surgery type, blood counts
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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