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

NCT ID: NCT04164095

Last Updated: 2019-12-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2025-12-31

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 influence of two surgical methods on the long-term quality of life of patients after operation

Conditions

Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

lappg

Group Type: EXPERIMENTAL

lappg

Intervention Type: PROCEDURE

Preservation of pylorus and vagus nerve by laparoscopy

ladgbi

Group Type: ACTIVE_COMPARATOR

lappg

Intervention Type: PROCEDURE

Preservation of pylorus and vagus nerve by laparoscopy

Interventions

lappg

Preservation of pylorus and vagus nerve by laparoscopy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. 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.

Exclusion Criteria

1. pregnant or lactating women; suffering from serious mental illness;

2. the history of upper abdominal surgery (except laparoscopic cholecystectomy);

3. history of gastric surgery (including ESD / EMR for gastric cancer);

4. preoperative imaging examination showed regional enlarged lymph nodes;

5. having other malignant diseases within 5 years;

6. patients with gastric cancer who have received new adjuvant therapy or recommended new adjuvant therapy;

7. there was a history of unstable angina or myocardial infarction within 6 months;

8. have a history of cerebral infarction or cerebral hemorrhage within 6 months;

9. there was a history of continuous systemic corticosteroid therapy within 1 month;

10. simultaneous surgical treatment of other diseases is needed;

11. gastric cancer with complications (hemorrhage, perforation, obstruction) requires emergency surgery;

12. FEV1 of pulmonary function examination was less than 50% of the predicted value.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

The First Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role: collaborator

Affiliated Hospital of Qinghai University

OTHER

Sponsor Role: collaborator

Zhejiang Cancer Hospital

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital of Suzhou University

OTHER

Sponsor Role: collaborator

Responsible Party

zhaogang

PROFESSOR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

LVLM

Identifier Type: -

Identifier Source: org_study_id