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

NCT04164095 | Unknown DMC

• 1 other identifier: LVLM
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• EORTC-QLQ-C30

  score: 0-100. more global and functional scales is better. less symptom scales is better

  5 years

Study Arms (2)

lappg

EXPERIMENTAL

Procedure: lappg

ladgbi

ACTIVE COMPARATOR

Procedure: lappg

Interventions

lappg PROCEDURE

Preservation of pylorus and vagus nerve by laparoscopy

ladgbi; lappg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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.

Sponsors & Collaborators

• RenJi Hospital: lead
• The First Affiliated Hospital of Dalian Medical University: collaborator
• Affiliated Hospital of Qinghai University: collaborator
• Zhejiang Cancer Hospital: collaborator
• Second Affiliated Hospital of Suzhou University: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 15, 2019
• Study Start: January 1, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 5, 2019

Record last verified: 2019-11