Laparoscopic-assisted Distal Gastrectomy and Totally Laparoscopic Distal Gastrectomy for Gastric Cancer

Fudan University

Status: Completed

Conditions: Gastric Cancer

Treatments: Procedure: Totally laparoscopic distal gastrectomy; Procedure: laparoscopy-assisted distal gastrectomy Group

Study type: Interventional

Funder types: Other

Identifiers

NCT05541783

LATDG

Details and patient eligibility

About

The aim of this study is comparing the short-term quality of life between laparoscopy-assisted distal gastrectomy and totally laparoscopic distal gastrectomy for gastric cancer.

Enrollment: 213 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 20-80 years;
2. Patients had an Eastern Cooperative Oncology Group performance status score of 0 or 1;
3. Patients had histologically confirmed gastric adenocarcinoma (tumor size<5cm) at clinical stage I-III with T1-4aN0-2M0 excluding T4b or N3 tumors, according to the of the American Joint Committee on Cancer classification system, eighth edition;
4. Patients were expected to undergo laparoscopic distal gastrectomy with D2 lymphadenectomy.

Exclusion criteria

1. Patients had bulky regional lymph nodes (larger than 3 cm at the long diameter) or possible distant metastasis in preoperative evaluation
2. Patients had history of chemotherapy, radiotherapy, immunotherapy or target therapy;
3. Patients had any concurrent or previous malignant tumor;
4. Patients had unstable cardiovascular, respiratory, kidney, or liver disease and poorly controlled hypertension, diabetes, mental disorders; history of upper abdominal surgery (except laparoscopic cholecystectomy).
5. Patients were histologically proven gastric adenocarcinoma (by preoperative gastrofiberscopy).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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213 participants in 2 patient groups

Laparoscopy-assisted distal gastrectomy

Active Comparator group

Description:

The patients who are assigned to LADG group undergo extracorporeal anasto- mosis for gastrointestinal reconstruction.

Treatment:

Procedure: laparoscopy-assisted distal gastrectomy Group

Totally laparoscopic distal gastrectomy

Experimental group

Description:

The patients who are allocated to TLDG group undergo intracorporeal anastomosis for the recovery of gastrointes- tinal continuity after gastrectomy.

Treatment:

Procedure: Totally laparoscopic distal gastrectomy