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NCT Number: NCT05235932

the Clinical Efficacy of Robotic and Laparoscopic Radical Total Gastrectomy in Locally Advanced Middle and Upper Gastric Cancer

To evaluate the clinical efficacy (safety, feasibility and long-term efficacy) of robotic radical total gastrectomy and laparoscopic radical total gastrectomy in patients with locally advanced middle and upper gastric adenocarcinoma (CT2-4A, N-/+, M0) .

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

About this study

In the field of gastrectomy, Hashizume et al. first reported robotic gastrectomy in 2002. Since then, reports on the safety and feasibility of the application of robotic surgical system in the treatment of gastric cancer (GC) have gradually increased. Reports of robotic surgery for GC are increasing, especially in Asia. Several studies confirmed the advantages of robotic gastrectomy when compared with laparoscopic gastrectomy. However, whether robotic radical total gastrectomy is noninferior to laparoscopic radical total gastrectomy remains unclear. The investigator first carried out this study in the world to evaluate the efficacy of robotic radical total gastrectomy versus laparoscopic radical total gastrectomy for GC.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1.Age between 18 and 75 years 2.The primary gastric lesion was histopathologically diagnosed as middle and upper gastric adenocarcinoma (papillary adenocarcinoma PAP, tubular adenocarcinoma TUB, mucinous adenocarcinoma MUC, signed-ring cell carcinoma SIG, poorly differentiated adenocarcinoma POR) by endoscopic biopsy.

3.Preoperative clinical stages were CT2-4A、 N-/+、and M0 (according to AJCC-8th TNM tumor staging) 4.Excepting to perform radical total gastrectomy and D2 lymph node dissection can achieve R0 resection.

5.American Society of Anesthesiology (ASA) score class I, II, or III 6.Written informed consent

Exclusion criteria

  • Preoperative examination suggested disease staging cT1, N-/+, and M0 (according to AJCC-8th TNM tumor staging )
  • Women during pregnancy or breast-feeding
  • Severe mental disorder
  • History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
  • History of previous gastrectomy(except for ESD/EMR for gastric cancer )
  • Enlarged or bulky regional lymph node over 3 cm by preoperative imaging
  • History of other malignant disease within the past five years
  • History of previous neoadjuvant chemotherapy or radiotherapy
  • History of unstable angina or myocardial infarction within past six months
  • History of cerebrovascular accident within past six months
  • History of continuous systematic administration of corticosteroids within one month
  • Requirement for simultaneous surgery for other disease(except laparoscopic cholecystectomy)
  • Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
  • FEV1 (forced expiratory volume in one second)<50% of predicted values

Treatment and study plan

Robotic radical total gastrectomy with D2 lymphadenectomy

Procedure

Most surgical procedures are performed using the robot system.

Laparoscopic radical total gastrectomy with D2 lymphadenectomy

Procedure

Without the robot system, Most surgical procedures are performed using laparoscopic equipment.

Primary outcomes

  1. 3-year disease free survival rate

    Time frame: 36 months

    3-year disease free survival rate

Secondary outcomes

  1. Morbidity rates

    Time frame: 30 days

    This is for the early postoperative complication, which defined as the event observed within 30 days after surgery.

  2. 3-year overall survival rate

    Time frame: 36 months

    3-year overall survival rate

  3. 3-year recurrence pattern

    Time frame: 36 months

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

  4. intraoperative morbidity rates

    Time frame: 1 day

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

  5. overall postoperative serious morbidity rates

    Time frame: 30 days

    Refers to the incidence of early postoperative complication which is graded as Clavien-Dindo IIIA or higher

  6. Total Number of Retrieved Lymph Nodes

    Time frame: 1 day

    Total Number of Retrieved Lymph Nodes

  7. postoperative recovery course

    Time frame: 30 days

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

  8. postoperative nutritional status

    Time frame: 3, 6, 9 and 12 months

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

  9. inflammatory immune response

    Time frame: Preoperative 3 days and postoperative 1, 3, and 5 days

    The variation 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

Study contacts

Contact information is provided by the study sponsor or research team.

Chang-ming Huang, MD

CONTACT

[email protected]

+86-13805069676

Hua-long Zheng, MD

CONTACT

[email protected]

+86-18359190587

Sponsors and collaborators

Lead sponsor

Fujian Medical University

Other

Collaborators

  • Chinese PLA General Hospital
  • First Affiliated Hospital Xi'an Jiaotong University
  • First Affiliated Hospital of Guangxi Medical University
  • Gansu Provincial Hospital
  • Hebei Medical University Fourth Hospital
  • Lanzhou Military Region General Hospital
  • Second Xiangya Hospital of Central South University
  • Southwest Hospital, China
  • The Affiliated Hospital of Qingdao University
  • The First Affiliated Hospital of Nanchang University
  • The Second Affiliated Hospital of Dalian Medical University
  • Tianjin Medical University Cancer Institute and Hospital

Registry information

Official study title

A Prospective, Multicenter, Randomized, Controlled Study of the Clinical Efficacy of Robotic and Laparoscopic Radical Total Gastrectomy in Locally Advanced Middle and Upper Gastric Cancer

Important dates

Study start
2022
Primary completion
2024
Study completion
2027
First posted
Feb 11, 2022
Registry last updated
Feb 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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