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Stomach NeoplasmsNCT03524287

Robotic Total Gastrectomy for Locally Advanced Proximal Gastric Cancer

A study testing Robotic Assisted No.10 Lymph Node Dissections in people with Stomach Neoplasms, run by Fujian Medical University 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

The purpose of this study is to explore the clinical Efficacy of robotic assisted spleen-preserving No. 10 lymph node dissection for patients with locally advanced upper third gastric adenocarcinoma（cT2-4a, N-/+, M0）. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Stomach Neoplasms
What is being tested?
Robotic Assisted No.10 Lymph Node Dissections
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
1 Mar 2018to 10 Mar 2020
Phase
Interventional
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 18 to 75 years old
  • Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
  • Locally advanced tumor in the upper third or middle third of stomach without invading the greater curvature (cT2-4a, N-/+, M0 at preoperative evaluation according to the AJCC (American Joint Committee on Cancer) Cancer Staging Manual Seventh Edition)
  • No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations
  • Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
  • ASA (American Society of Anesthesiology) class I to III
  • Written informed consent

Who cannot join

  • Pregnant and lactating women
  • Suffering from severe mental disorder
  • History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
  • History of previous gastric surgery (including ESD/EMR (Endoscopic Submucosal --Dissection/Endoscopic Mucosal Resection )for gastric cancer)
  • Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging including enlarged or bulky No.10 lymph node
  • History of other malignant disease within the past 5 years
Show all 14Show fewer
  • History of previous neoadjuvant chemotherapy or radiotherapy
  • History of unstable angina or myocardial infarction within the past 6 months
  • History of cerebrovascular accident within the past 6 months
  • History of continuous systematic administration of corticosteroids within 1 month
  • Requirement of simultaneous surgery for other disease
  • Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
  • FEV1<50% of the predicted values
  • Splenectomy must be performed due to the obvious tumor invasion in spleen or spleen blood vessels.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

Other trials in China

About this study

Official title: Clinical Efficacy of Robotic Total Gastrectomy With D2 Lymph Node Dissection for Locally Advanced Proximal Gastric Cancer：A Prospective Trial

The purpose of this study is to explore the clinical Efficacy of robotic assisted spleen-preserving No. 10 lymph node dissection for patients with locally advanced upper third gastric adenocarcinoma（cT2-4a, N-/+, M0）.

Read the detailed description

The incidence of No. 10 lymph node metastasis is high in advanced proximal gastric cancer, reported to range from 9.8%-20.9%, and the presence of No. 10 lymph node metastasis is closely related to survival. Therefore, in East Asia, D2 lymph node dissection of potentially curable locally advanced upper third gastric cancer including No. 10 lymph node is the standard surgical treatment.

Robotic surgery has been developed with the aim of improving surgical quality and overcoming the limitations of conventional laparoscopy in the performance of complex mini-invasive procedures. However, it remains a controversial international issue if it is safe and feasible to conduct robotic assisted spleen-preserving No. 10 lymph node dissection for advanced upper third gastric cancer. There is no prospective study to identify the results.

The study is through a prospective, open, single-arm study,to explore the clinical outcomes of the robotic assisted spleen-preserving No. 10 lymph node dissection in the treatment of locally advanced gastric adenocarcinoma （cT2-4a, N-/+, M0）.

Being tested
Robotic Assisted No.10 Lymph Node Dissections
Keywords
Stomach Neoplasms, Robotic Surgery, Spleen-Preserving, No.10 Lymph Node Dissection
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 Assisted No.10 Lymph Node DissectionsProcedure or surgery

    After exclusion of T4b, bulky lymph nodes, or distant metastasis case et al. Robotic assisted spleen-preserving No.10 lymph node dissections will be performed with curative treated intent in patients with locally advanced upper third gastric adenocarcinoma

Study groups in NCT03524287
Study groupRoleWhat they receive
No.10 lymph node dissectionsExperimentalPatients with locally advanced upper third gastric carcinoma will performed robotic assisted spleen-preserving No.10 lymph node dissections. After the surgery the patients will be treated with oxaliplatin or platinum-based chemotherapy.
Receives: Procedure: Robotic Assisted No.10 Lymph Node Dissections

What is being measured

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

  1. overall postoperative morbidity rates

    Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery

    Measured: 30 days

Secondary outcomes (19)

  1. Numbers of No.10 lymph node dissection

    Numbers of dissected No.10 lymph nodes

    Measured: 9 days

  2. Rates of positive No.10 lymph node

    The Rates of positive No.10 lymph node are defined as the incidence of positive No.10 lymph node (divide number of positive No.10 lymph nodes by number of total No.10 lymph nodes)

    Measured: 9 days

  3. 3-year overall survival rate

    3-year overall survival rate

    Measured: 36 months

  4. 3-year disease free survival rate

    3-year disease free survival rate

    Measured: 36 months

  5. 3-year recurrence pattern

    Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type

    Measured: 36 months

  6. Rates of splenectomy

    The Rates of splenectomy are defined as the incidence of splenectomy within operation.

    Measured: 1 days

  7. Intraoperative morbidity rates

    The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.

    Measured: 1 days

  8. Time to first ambulation

    Time to first ambulation in hours is used to assess the postoperative recovery course.

    Measured: 30 days

  9. Time to first flatus

    Time to first flatus in days is used to assess the postoperative recovery course.

    Measured: 30 days

  10. Time to first liquid diet

    Time to first liquid diet in days is used to assess the postoperative recovery course.

    Measured: 30 days

  11. Time to first soft diet

    Time to first soft diet in days is used to assess the postoperative recovery course.

    Measured: 30 days

  12. Duration of postoperative hospital stay

    Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.

    Measured: 30 days

  13. The variation of weight

    The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.

    Measured: 3, 6, 9 and 12 months

  14. The variation of album

    The variation of album in gram/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.

    Measured: 3, 6, 9 and 12 months

  15. The variation of white blood cell count

    The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.

    Measured: Preoperative 3 days and postoperative 1, 3, and 5 days

  16. The variation of C-reactive protein

    The values of C-reactive protein IN milligram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.

    Measured: Preoperative 3 days and postoperative 1, 3, and 5 days

  17. Technical performance

    Technical performance were assessed by the Objective Structured Assessments of Technical Skills (OSATS) and the Generic Error Rating Tool.

    Measured: 1 days

  18. The Surgery Task Load Index (SURG-TLX)

    Surgeons were required to complete one modified SURG-TLX questionnaire for each procedure.

    Measured: 1 days

  19. Lymph node noncompliance rate

    Lymph node noncompliance was defined as the absence of lymph nodes that should have been excised from more than 1 lymph node station. Major lymph node noncompliance was defined as more than 2 intended lymph node stations that were not removed.

    Measured: 1 days

Timeline

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

  1. First posted14 May 2018
  2. Study start1 Mar 2018
  3. Primary completion10 Feb 2020
  4. Study completion10 Mar 2020

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
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03524287
Sponsor's protocol ID
FUGES-014
Status last verified
Sep 2020
First submitted
2 May 2018
Last updated
9 Sep 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Zhong Q, Zhang ZQ, Yan YQ, Li YF, He QC, Zheng CH, Chen QY, Huang CM. [Long-term oncological safety of robotic total gastrectomy for locally advanced proximal gastric cancer: a 5-year noninferiority comparison based on the FUGES-014 study]. Zhonghua Wei Chang Wai Ke Za Zhi. 2025 Aug 25;28(8):886-894. doi: 10.3760/cma.j.cn441530-20250610-00218. Chinese.

    PubMed 40850834

Questions about this trial

What is this clinical trial studying?

A study testing Robotic Assisted No.10 Lymph Node Dissections in people with Stomach Neoplasms, run by Fujian Medical University 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 7 inclusion and 14 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 9 Sep 2020. 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?

overall postoperative morbidity rates (time frame: 30 days). 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 NCT03524287, which also lists 1 linked publication.

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 9 Sep 2020.

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