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Gastric Cancer Patients Undergoing GastrectomyNCT07237126

Single-port Robotic Radical Gastrectomy for Gastric Cancer

A study testing Single-port Robotic Radical Gastrectomy for Gastric Cancer in people with Gastric Cancer Patients Undergoing Gastrectomy, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study is a single-center, phase 2a exploratory clinical study based on IDEAL framework. The intraoperative and postoperative complications were analyzed to evaluate the safety, feasibility and clinical efficacy of single-port robot-assisted gastric tumor resection. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Single-port Robotic Radical Gastrectomy for Gastric Cancer
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesChina
Study dates
22 Jul 2026to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • (1) Age: 18-75 years; (2) Histologically confirmed gastric adenocarcinoma by endoscopic biopsy; (3) Preoperatively staged as either endoscopically unresectable T1, or cT2-4a with or without nodal involvement (N-/+), and no distant metastasis (M0), according to the 7th edition of the AJCC Cancer Staging Manual; (4) Eligible for potentially curative surgical resection; (5) Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; (6) American Society of Anesthesiologists (ASA) physical status classification of I-III; (7) Provision of written informed consent.

Who cannot join

  • (1) Pregnant or lactating women; (2) Severe psychiatric disorder; (3) History of prior upper abdominal surgery; (4) Previous gastrectomy, endoscopic submucosal dissection (ESD), or endoscopic mucosal resection (EMR); (5) Preoperative imaging showing regional lymphadenopathy with lymph node(s) larger than 3 cm in diameter; (6) History of another primary malignancy within the past 5 years; (7) Prior neoadjuvant chemotherapy or radiotherapy; (8) History of cerebrovascular or cardiovascular event (e.g., stroke or myocardial infarction) within the past 6 months; (9) Systemic corticosteroid use for more than one month within the past month; (10) Requirement for concomitant surgery for other conditions; (11) Need for emergency surgery due to gastric cancer-related complications (e.g., bleeding, obstruction, or perforation); (12) Participation in another interventional clinical trial previously; (13) Active severe infectious disease; (14) Severe systemic disease.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

China2 sites, 2 recruiting
  • Daping Hospital

    Chongqing, Chongqing Municipality, 400042

    Chuan Huang, 86-13140290998, 331998408@qq.com

    Not yet recruiting
  • Daping Hospital of Army Medical Universty

    Chongqing

    Chao Hui Zheng, 8023-68729350, 625730455@qq.com

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety Assessment of Single-port Robotic Radical Gastrectomy for Gastric Cancer: a Phase 2a Trial Based on the IDEAL Framework

This study is a single-center, phase 2a exploratory clinical study based on IDEAL framework. The intraoperative and postoperative complications were analyzed to evaluate the safety, feasibility and clinical efficacy of single-port robot-assisted gastric tumor resection.

Read the detailed description

The study assessed the intraoperative adverse events (device-related and/or procedure-related), postoperative complications, perioperative recovery outcomes, surgical specimen quality, and pathological indices of Single-port robot-assisted radical gastrectomy for gastric cancer.

Being tested
Single-port Robotic Radical Gastrectomy for Gastric Cancer
Keywords
Single-port robotic, Gastric cancer, Radical Gastrectomy
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • Single-port Robotic Radical Gastrectomy for Gastric CancerProcedure or surgery

    Single-port Robotic Radical Gastrectomy for Gastric Cancer

Study groups in NCT07237126
Study groupRoleWhat they receive
Single-port Robotic Radical Gastrectomy for Gastric CancerExperimentalSingle-port Robotic Radical Gastrectomy for Gastric Cancer
Receives: Procedure: Single-port Robotic Radical Gastrectomy for Gastric Cancer

What is being measured

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

  1. Intraoperative adverse events and 30-day postoperative complications

    Intraoperative adverse events (device and/or procedure-related). Events were recorded as Preferred Term and classified under System Organ Class as per MedDRA Common Terminology Criteria for Adverse Events (CTCAE) coding guidelines (https://evs.nci.nih.gov/ftp1/CTCAE/About.html). Postoperative complications will refer to any medical occurrence directly attributed to the surgical procedure within the first 30 days.

    Measured: Intraoperative and postoperative 30 days

  2. Conversion rate

    Conversion to open or laparotomy surgery due to intraoperative complications , technical difficulties, or inability to successfully complete predefined procedural steps .

    Measured: Intraoperative

Secondary outcomes (5)
  1. Length of incision

    The total length (in centimeters) of the surgical skin incision made during the procedure, measured immediately after wound closure.

    Measured: Intraoperative

  2. Intraoperative Blood Loss

    The estimated volume of blood lost during surgery (in milliliters), calculated based on suction collection volume and the weight of used gauze sponges, using standard conversion methods.

    Measured: Intraoperative

  3. Operative Time

    The duration (in minutes) from the initial skin incision to final wound closure, excluding anesthesia induction and emergence.

    Measured: Intraoperative

  4. Postoperative Length of Hospital Stay

    The number of days between the day of surgery (postoperative day 0) and the day of hospital discharge, inclusive of the discharge day if applicable per institutional protocol.

    Measured: 7 days after surgery

  5. Number of Lymph Nodes Harvested

    The total count of lymph nodes removed during the lymphadenectomy and confirmed by pathological examination.

    Measured: 7 days 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 posted19 Nov 2025
  2. Study start22 Jul 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07237126
Sponsor's protocol ID
SPORTS-04
Status last verified
Aug 2026
First submitted
16 Nov 2025
Last updated
4 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ito A, Nakauchi M, Fujita M, Umeki Y, Suzuki K, Serizawa A, Akimoto S, Watanabe Y, Tanaka T, Shibasaki S, Inaba K, Uyama I, Suda K. Initial clinical experiences of robotic distal gastrectomy for gastric cancer using the Da Vinci SP system: a single-center retrospective study. Langenbecks Arch Surg. 2025 Mar 29;410(1):110. doi: 10.1007/s00423-025-03685-w.

    PubMed 40156763
  • Park SH, Kim YN, Hwang J, Kim KY, Cho M, Kim YM, Hyung WJ, Kim HI. Safety and feasibility of reduced-port robotic distal gastrectomy for gastric cancer: a phase I/II clinical trial using the da Vinci Single Port(SP) robotic system. Sci Rep. 2023 Oct 30;13(1):18578. doi: 10.1038/s41598-023-45655-6.

    PubMed 37903856
  • Shang L, Zhang R, Dong K, Xiao K, Zheng C, Shi Y, Liu H, Jing C, Li L. The world's first pure single-port robotic radical total gastrectomy for advanced gastric cancer. Chin Med J (Engl). 2024 Dec 20;137(24):3151-3152. doi: 10.1097/CM9.0000000000003380. Epub 2024 Nov 28. No abstract available.

    PubMed 39604102
  • Qiu WW, Huang ZN, Li TY, Zhang L, She JJ, Jia BQ, Qin XG, Ren SY, Yao HL, Liu DN, Liang H, Shi FY, Li P, Li BP, Zhang XS, Liu KJ, Zheng CH, Lin JX, Huang CM, Li P. Comparison of short- and mid-term outcomes of robotic versus laparoscopic gastrectomy in high-risk patients with gastric cancer: a nationwide, multicentre cohort study. Eur J Surg Oncol. 2025 Oct;51(10):110294. doi: 10.1016/j.ejso.2025.110294. Epub 2025 Jul 3.

    PubMed 40651456
  • Keller DS, Reif de Paula T, Ikner TP, Saidi H, Schoonyoung H, H Marks J. Perioperative outcomes for single-port robotic versus single-incision laparoscopic surgery: a comparative analysis in colorectal cancer surgery. Surg Endosc. 2024 Mar;38(3):1568-1575. doi: 10.1007/s00464-023-10629-2. Epub 2024 Jan 4.

    PubMed 38177611
  • Cheng X, Huang C, Jia W, Guo Z, Shi Y, Song Z, Feng H, Huang H, Xu S, Li H, Wang S, Zhang Y, Zhang T, Liu K, Ji X, Zhao R. Clinical status and future prospects of single-incision robotic-assisted surgery: a review. Int J Surg. 2023 Dec 1;109(12):4221-4237. doi: 10.1097/JS9.0000000000000944.

    PubMed 37988410
  • Cianchi F, Staderini F, Badii B. Single-incision laparoscopic colorectal surgery for cancer: state of art. World J Gastroenterol. 2014 May 28;20(20):6073-80. doi: 10.3748/wjg.v20.i20.6073.

    PubMed 24876729
  • Markar SR, Karthikesalingam A, Di Franco F, Harris AM. Systematic review and meta-analysis of single-incision versus conventional multiport appendicectomy. Br J Surg. 2013 Dec;100(13):1709-18. doi: 10.1002/bjs.9296.

    PubMed 24227355
  • Haueter R, Schutz T, Raptis DA, Clavien PA, Zuber M. Meta-analysis of single-port versus conventional laparoscopic cholecystectomy comparing body image and cosmesis. Br J Surg. 2017 Aug;104(9):1141-1159. doi: 10.1002/bjs.10574. Epub 2017 Jun 1.

    PubMed 28569406
  • Seo HS, Lee HH. Is the 5-ports approach necessary in laparoscopic gastrectomy? Feasibility of reduced-port totally laparoscopic gastrectomy for the treatment of gastric cancer: A Prospective Cohort Study. Int J Surg. 2016 May;29:118-22. doi: 10.1016/j.ijsu.2016.03.035. Epub 2016 Mar 28.

    PubMed 27034118
  • Liu Y, Yun H, Zhang W, Zou H, Chen N, Wang Y, Luo Z, Xu X, Sun Y, Chen Y, Beznosenko A, ALMasri H, McClure MA, Ma H, Yu J, Lv Q. Robotic versus laparoscopic total gastrectomy for gastric cancer: a systematic review and meta-analysis of perioperative and oncologic outcomes. Int J Surg. 2025 Sep 1;111(9):6397-6411. doi: 10.1097/JS9.0000000000002761. Epub 2025 Jun 19.

    PubMed 40549444
  • Li Z, Zhou W, Yang W, Miao Y, Zhang Y, Duan L, Niu L, Chen J, Fan A, Xie Q, Wei S, Bai H, Wang C, Chen X, Han Y, Hong L. Efficacy and safety of robotic vs. laparoscopic gastrectomy for patients with gastric cancer: systematic review and meta-analysis. Int J Surg. 2024 Dec 1;110(12):8045-8056. doi: 10.1097/JS9.0000000000001826.

    PubMed 38874467
  • Jayne D, Pigazzi A, Marshall H, Croft J, Corrigan N, Copeland J, Quirke P, West N, Rautio T, Thomassen N, Tilney H, Gudgeon M, Bianchi PP, Edlin R, Hulme C, Brown J. Effect of Robotic-Assisted vs Conventional Laparoscopic Surgery on Risk of Conversion to Open Laparotomy Among Patients Undergoing Resection for Rectal Cancer: The ROLARR Randomized Clinical Trial. JAMA. 2017 Oct 24;318(16):1569-1580. doi: 10.1001/jama.2017.7219.

    PubMed 29067426
  • Kim HH, Han SU, Kim MC, Kim W, Lee HJ, Ryu SW, Cho GS, Kim CY, Yang HK, Park DJ, Song KY, Lee SI, Ryu SY, Lee JH, Hyung WJ; Korean Laparoendoscopic Gastrointestinal Surgery Study (KLASS) Group. Effect of Laparoscopic Distal Gastrectomy vs Open Distal Gastrectomy on Long-term Survival Among Patients With Stage I Gastric Cancer: The KLASS-01 Randomized Clinical Trial. JAMA Oncol. 2019 Apr 1;5(4):506-513. doi: 10.1001/jamaoncol.2018.6727.

    PubMed 30730546
  • Katai H, Mizusawa J, Katayama H, Morita S, Yamada T, Bando E, Ito S, Takagi M, Takagane A, Teshima S, Koeda K, Nunobe S, Yoshikawa T, Terashima M, Sasako M. Survival outcomes after laparoscopy-assisted distal gastrectomy versus open distal gastrectomy with nodal dissection for clinical stage IA or IB gastric cancer (JCOG0912): a multicentre, non-inferiority, phase 3 randomised controlled trial. Lancet Gastroenterol Hepatol. 2020 Feb;5(2):142-151. doi: 10.1016/S2468-1253(19)30332-2. Epub 2019 Nov 19.

    PubMed 31757656

Questions about this trial

What is this clinical trial studying?

A study testing Single-port Robotic Radical Gastrectomy for Gastric Cancer in people with Gastric Cancer Patients Undergoing Gastrectomy, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 2 sites 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: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Fan Li MD (0008602368757350, Levinecq@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intraoperative adverse events and 30-day postoperative complications (time frame: Intraoperative and postoperative 30 days). The study lists 2 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 NCT07237126, which also lists 21 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 4 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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