NCT04351321

Brief Summary

To compare the short-term surgical safety and postoperative quality of life of totally laparoscopic versus laparoscopy-assisted total gastrectomy and to evaluate the superiority of totally laparoscopic total gastrectomy.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
560

participants targeted

Target at P75+ for not_applicable gastric-cancer

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable gastric-cancer

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 17, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

April 17, 2020

Status Verified

April 1, 2020

Enrollment Period

2.1 years

First QC Date

April 13, 2020

Last Update Submit

April 16, 2020

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • The incidence of postoperative morbidity

    Refers to the incidence of early postoperative complications. The early postoperative complications are defined as the events observed within postoperative 30 days.

    30 days

Secondary Outcomes (3)

  • Quality of life score

    3, 6 and 12 months

  • Quality of life score

    3, 6 and 12 months

  • Overall incidence of postoperative morbidity

    12 months

Study Arms (2)

Totally Laparoscopic Total Gastrectomy

EXPERIMENTAL

Totally laparoscopic total gastrectomy will be performed for the treatment of patients assigned to this group.

Procedure: Totally Laparoscopic Total Gastrectomy

Laparoscopy-Assisted Total Gastrectomy

ACTIVE COMPARATOR

Laparoscopy-assisted total gastrectomy will be performed for the treatment of patients assigned to this group.

Procedure: Laparoscopy-Assisted Total Gastrectomy

Interventions

Totally Laparoscopic Total GastrectomyPROCEDURE

Totally laparoscopic total gastrectomy will be performed in patients with gastric or esophagogastric junction adenocarcinoma of preoperative clinical stage I (T1N0M0, T1N1M0, T2N0M0) with D1+/D2 lymph node dissection.

Totally Laparoscopic Total Gastrectomy
Laparoscopy-Assisted Total GastrectomyPROCEDURE

Laparoscopy-Assisted Total Gastrectomy will be performed in patients with gastric or esophagogastric junction adenocarcinoma of preoperative clinical stage I (T1N0M0, T1N1M0, T2N0M0) with D1+/D2 lymph node dissection.

Laparoscopy-Assisted Total Gastrectomy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18-75 years；
  • Primary lesion is diagnosed with endometrial biopsy as adenocarcinoma of the stomach or esophagogastric junction, including: papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), mixed adenocarcinoma, etc.；
  • Clinical stage cT1N0M0, cT1N1M0, cT2N0M0；
  • The gastric primary lesion is located in the body or fundus of stomach or the esophagogastric junction. It is expected that total gastrectomy with D1+/D2 lymph node dissection achieves R0 resection (multiple primary cancers are also applicable)；
  • BMI(Body Mass Index)\<30 kg/m2；
  • No history of upper abdominal surgery (except for laparoscopic cholecystectomy)；
  • No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.；
  • Preoperative ECOG (Eastern Cooperative Oncology Group) performance status score 0 or 1；
  • Preoperative ASA (American Society of Anesthesiologists) scoring I-III；
  • Sufficient vital organ functions；
  • Signed informed consent.

You may not qualify if:

  • Preoperative examination indicates disease stage cStage II or above；
  • Women during pregnancy or lactation；
  • Suffer from other malignant tumors within 5 years；
  • Preoperative body temperature ≥ 38°C or complicated with infectious diseases requiring systemic treatment；
  • Severe mental illness；
  • Severe respiratory disease；
  • Severe liver and kidney dysfunction；
  • History of unstable angina or myocardial infarction within 6 months；
  • History of cerebral infarction or cerebral hemorrhage within 6 months；
  • Continuous application of glucocorticoid within 1 month (except for topical application)；
  • Accompanied by gastric cancer complications (bleeding, perforation, obstruction, etc.) ；
  • The patient has participated in or is participating in other clinical studies (within 6 months).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Central Study Contacts

Zekuan Xu, M.D., Ph.D.

CONTACT

+86-025-68306844xuzekuan@njmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2020

First Posted

April 17, 2020

Study Start

July 1, 2020

Primary Completion

August 1, 2022

Study Completion

August 1, 2023

Last Updated

April 17, 2020

Record last verified: 2020-04