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Completed

NCT Number: NCT03313700

Clinical Outcomes of Robotic Versus Laparoscopic Distal Gastrectomy for Gastric Cancer

The purpose of this study is to explore the clinical outcomes of the robotic distal gastrectomy for patients with gastric adenocarcinoma（cT1-4a, N-/+, M0）.

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Key information

Conditions

Stomach Neoplasm Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Robotic Surgery Stomach Diseases Stomach Neoplasms

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, 350000, China

About this study

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. The study is designed to explore the clinical outcomes of the robotic distal gastrectomy by comparing short- and long-term outcomes including financial cost of robotic and laparoscopic distal gastrectomy in the treatment of gastric adenocarcinoma （cT1-4a, N-/+, M0）.

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 dissction to obtain R0 resection sugicall results.
  • 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

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 ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )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
  • FEV1<50% of the predicted values

Treatment and study plan

Robotic Distal Gastrectomy

Procedure

After exclusion of T4b, bulky lymph nodes, or distant metastasis case, robotic distal gastrectomy will be performed in the experimental group.

Laparoscopic distal gastrectomy

Procedure

After exclusion of T4b, bulky lymph nodes, or distant metastasis case, laparoscopic distal gastrectomy will be performed in the comparator group.

Primary outcomes

  1. 3-year disease free survival rate

    Time frame: 36 months

    the rate of 3-year disease free survival

Secondary outcomes

  1. 3-year overall survival rate

    Time frame: 36 months

    the rate of 3-year overall survival rate

  2. 3-year recurrence pattern

    Time frame: 36 months

    the pattern of recurrence in 3 years

  3. overall postoperative morbidity rates

    Time frame: 30 days

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

  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. number of retrieved lymph nodes

    Time frame: 1 days

    number of retrieved lymph nodes

  7. the noncompliance rate of lymphadenectomy

    Time frame: 1 days

    the noncompliance rate of lymphadenectomy

  8. Time to first ambulation

    Time frame: 30 days

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

  9. Time to first flatus

    Time frame: 30 days

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

  10. Time to first liquid diet

    Time frame: 30 days

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

  11. Time to first soft diet

    Time frame: 30 days

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

  12. Duration of postoperative hospital stay

    Time frame: 30 days

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

  13. The variation of weight

    Time frame: 3, 6, 9 and 12 months

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

  14. The variation of cholesterol

    Time frame: 3, 6, 9 and 12 months

    The variation of cholesterol in millimole/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status.

  15. The variation of album

    Time frame: 3, 6, 9 and 12 months

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

  16. The variation of white blood cell count

    Time frame: Preoperative 7 days and postoperative 1 and 5 days

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

  17. The variation of hemoglobin

    Time frame: Preoperative 7 days and postoperative 1 and 5 days

    The values of hemoglobin in gram/liter from peripheral blood before operation and on postoperative day 1, 5 are recorded to access the inflammatory response.

  18. Hospitalization expenses

    Time frame: 30 days

    The cost from admission to discharge

  19. operation time

    Time frame: 1 days

    operation time

Sponsors and collaborators

Lead sponsor

Fujian Medical University

Other

Registry information

Official study title

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

Acronym: RDG

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Oct 18, 2017
Registry last updated
Jun 22, 2023

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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