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

A Multicenter Randomized Controlled Study of the Effect of Laparoscopic Preservation of the Pylorus and Vagus Nerve on the Postoperative Quality of Life in Patients With Early Gastric Cancer

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

Study Overview

• Status: Not yet recruiting
• Conditions: Quality of Life
• Intervention / Treatment: Procedure: lappg

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: lappg	Procedure: lappg; Preservation of pylorus and vagus nerve by laparoscopy
ACTIVE_COMPARATOR: ladgbi	Procedure: lappg; Preservation of pylorus and vagus nerve by laparoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EORTC-QLQ-C30	score: 0-100. more global and functional scales is better. less symptom scales is better	5 years

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Collaborators: Zhejiang Cancer Hospital; The First Affiliated Hospital of Dalian Medical University; Affiliated Hospital of Qinghai University; Second Affiliated Hospital of Suzhou University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2020
• Primary Completion (ANTICIPATED): December 31, 2025
• Study Completion (ANTICIPATED): December 31, 2025

Study Registration Dates

• First Submitted: November 12, 2019
• First Submitted That Met QC Criteria: November 12, 2019
• First Posted (ACTUAL): November 15, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 5, 2019
• Last Update Submitted That Met QC Criteria: December 3, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: LVLM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No