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NCT Number: NCT04795063

Total Robotic Versus Robotic Assisted Distal Gastrectomy for Gastric Cancer

To evaluate the clinical efficacy (safety, feasibility and long-term efficacy) of total robotic versus robotic assisted distal gastrectomy for patients with gastric cancer (cT1-4a, N0/+, 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

Location contact

Changming Huang, M.D., Ph.D.

CONTACT

[email protected]

+86-133-6591-0253

Changming Huang, M.D., Ph.D.

PRINCIPAL_INVESTIGATOR

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 total robotic gastrectomy is noninferior to robotic-assisted gastrectomy remains unclear. The investigator first carried out this study in the world to evaluate the efficacy of total robotic versus robotic assisted distal gastrectomy for GC.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age from over 18 to under 75 years
  • Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
  • cT1-4a (clinical stage tumor), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
  • expected to perform distal gastrectomy with D1+/D2 lymph node dissection to obtain R0 resection surgicall results.
  • Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
  • American Society of Anesthesiology (ASA) class I to III
  • Written informed consent

Exclusion criteria

  • Women during pregnancy or breast-feeding
  • Severe mental disorder
  • History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
  • History of previous gastric surgery (except Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection (ESD/EMR) for gastric cancer)
  • Gastric multiple primary carcinoma
  • Enlarged or bulky regional lymph node (diameter over 3cm)supported by preoperative imaging
  • History of other malignant disease within the past 5 years
  • 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
  • Forced expiratory volume in 1 second (FEV1)<50% of the predicted values

Treatment and study plan

Total Robotic Distal Gastrectomy

Procedure

All the surgical procedures are performed using the robot system.

Robotic-Assisted Distal Gastrectomy

Procedure

After finishing the lymphadenectomy, the digestive tract reconstruction is performed extracorporal.

Primary 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.

Secondary outcomes

  1. 3-year disease free survival rate

    Time frame: 36 months

    3-year disease free survival rate

  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

  10. Time of digestive tract reconstruction

    Time frame: 1 day

    From the beginning to the end of digestive tract reconstruction

Study contacts

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

Chang-ming Huang, MD

CONTACT

[email protected]

+86-13805069676

Qi-yue Chen, PhD

CONTACT

[email protected]

+86-15980235636

Sponsors and collaborators

Lead sponsor

Fujian Medical University

Other

Registry information

Official study title

Randomized Controlled Trials on Clinical Outcomes of Total Robotic Versus Robotic Assisted Distal Gastrectomy for Gastric Cancer

Important dates

Study start
2021
Primary completion
2024
Study completion
2027
First posted
Mar 12, 2021
Registry last updated
Mar 12, 2021

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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