NCT04160962

Brief Summary

For the patients with early gastric cancer (T1), preoperative evaluation (gastroscope, ultrasound gastroscope and abdominal enhanced CT) showed that the tumor was located in the body of the stomach, and the margin was enough to retain the pylorus and non lymph node metastasis (N0). Lappg (D1 + lymph node dissection) and traditional laparoscopic distal gastrectomy (BII type anastomosis, D1 + lymph node dissection) were included A control study was conducted to evaluate the difference of long-term quality of life, gastric emptying rate, incidence of basic reflux gastritis, bile contraction function, immune index, nutritional index and disease-free survival and overall survival between the two groups.

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
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

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

November 4, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 13, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

November 13, 2019

Status Verified

November 1, 2019

Enrollment Period

2 years

First QC Date

November 4, 2019

Last Update Submit

November 8, 2019

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • EORTC Questionnaire QLQ-C30

    Among the multiple tools to evaluate QOL of postgastrectomy patients, the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire QLQ-C30 have been used most extensively.

    5 years

Study Arms (2)

lappg

Procedure: lappg

ladgbi

Procedure: lappg

Interventions

lappgPROCEDURE

Laparoscopic gastrectomy for pylorus preservation

ladgbilappg

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

For the patients with early gastric cancer (T1), preoperative evaluation (gastroscope, ultrasound gastroscope and abdominal enhanced CT) showed that the tumor was located in the body of the stomach, and the margin was enough to retain the pylorus and non lymph node metastasis (N0). Lappg (D1 + lymph node dissection) and traditional laparoscopic distal gastrectomy (BII type anastomosis, D1 + lymph node dissection) were included A control study was conducted to evaluate the influence of two surgical methods on the long-term quality of life of patients after operation

You may qualify if:

  • \) 18 years old \< age \< 75 years old;
  • (2) primary gastric lesions were diagnosed as gastric adenocarcinoma by biopsy;
  • (3) the preoperative clinical stage was T1N0M0 according to ajcc-7thtnm;
  • (4) it is predicted that R0 can be obtained by pylorogastric gastrectomy and D1 + lymph node dissection;
  • (5) preoperative ECoG physical state score 0 / 1;
  • (6) preoperative ASA score I-III;
  • (7) informed consent of patients.

You may not qualify if:

  • pregnant or lactating women; suffering from serious mental illness;
  • the history of upper abdominal surgery (except laparoscopic cholecystectomy);
  • history of gastric surgery (including ESD / EMR for gastric cancer);
  • preoperative imaging examination showed regional enlarged lymph nodes;
  • having other malignant diseases within 5 years;
  • patients with gastric cancer who have received new adjuvant therapy or recommended new adjuvant therapy;
  • there was a history of unstable angina or myocardial infarction within 6 months;
  • have a history of cerebral infarction or cerebral hemorrhage within 6 months;
  • there was a history of continuous systemic corticosteroid therapy within 1 month;
  • simultaneous surgical treatment of other diseases is needed;
  • gastric cancer with complications (hemorrhage, perforation, obstruction) requires emergency surgery;
  • FEV1 of pulmonary function examination was less than 50% of the predicted value.

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2019

First Posted

November 13, 2019

Study Start

January 1, 2020

Primary Completion

January 1, 2022

Study Completion

January 1, 2025

Last Updated

November 13, 2019

Record last verified: 2019-11