A Multicenter Randomized Controlled Study of the Effect of Laparoscopic Preservation of the Pylorus

Shanghai Jiao Tong University

Status

Not yet enrolling

Conditions

Quality of Life

Treatments

Procedure: lappg

Study type

Interventional

Funder types

Other

Identifiers

NCT04164095

LVLM

Details and patient eligibility

About

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

Enrollment

160 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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.