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Completed

NCT Number: NCT03524287

Robotic Total Gastrectomy for Locally Advanced Proximal Gastric Cancer

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).

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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

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).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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.

Treatment and study plan

Robotic Assisted No.10 Lymph Node Dissections

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Numbers of No.10 lymph node dissection

    Time frame: 9 days

    Numbers of dissected No.10 lymph nodes

  2. Rates of positive No.10 lymph node

    Time frame: 9 days

    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)

  3. 3-year overall survival rate

    Time frame: 36 months

    3-year overall survival rate

  4. 3-year disease free survival rate

    Time frame: 36 months

    3-year disease free survival rate

  5. 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

  6. Rates of splenectomy

    Time frame: 1 days

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

  7. Intraoperative morbidity rates

    Time frame: 1 days

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

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

  14. 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 and quality of life.

  15. The variation of white blood cell count

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

    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.

  16. The variation of C-reactive protein

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

    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.

  17. Technical performance

    Time frame: 1 days

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

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

    Time frame: 1 days

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

  19. Lymph node noncompliance rate

    Time frame: 1 days

    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.

Sponsors and collaborators

Lead sponsor

Fujian Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 14, 2018
Registry last updated
Sep 9, 2020

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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