ERAS for Patients Received Neoadjuvant Chemotherapy (ERASNAC)

JIANG Zhi-Wei

Status: Completed

Conditions: Gastric Cancer

Treatments: Procedure: SC group; Procedure: ERAS group

Study type: Interventional

Funder types: Other

Identifiers

NCT03272984

8150041701

Details and patient eligibility

About

Patients received neoadjuvant chemotherapy with locally advanced gastric caner undergo the enhanced recovery after surgery (ERAS) programs or the standard cares (SC) programs.

Full description

Before, most trials about the ERAS for radical gastrectomy demonstrated ERAS programs accelerate the postoperative rehabilitation of gastric cancer patients without increasing postoperative complications. However, in most trials, patients who received neoadjuvant chemotherapy were excluded. The investigators designed this trial for patients received neoadjuvant chemotherapy. In this trial, patients received neoadjuvant chemotherapy with locally advanced gastric caner undergo the ERAS programs or the SC programs. Finally, the investigators evaluated whether patients who receive neoadjuvant chemotherapy can be enrolled into the ERAS programs for locally advanced gastric cancer.

Enrollment: 114 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients received neoadjuvant chemotherapy with locally advanced gastric cancer.
2. Age older than 18 and younger than 75 years.
3. American Society of Anesthesiologists (ASA) class: I-III.
4. Participants can describe the symptom objectively and cooperate actively.
5. Written informed consent.

Exclusion criteria

1. Patients allergic to oxaliplatin, tegafur gimerac etc.
2. Patients with ischemic heart disease, cerebrovascular disease and peripheral vascular disease, or cardiac function > II (NYHA)
3. Patients with complications (bleeding, perforation and obstruction) caused by gastric cancer.
4. Patients with severe liver and renal dysfunction (Child - Pugh ≥ 10; Cr < 25 ml/min).
5. Patients who require simultaneous surgery for other diseases.
6. Patients who received upper abdominal surgery previously.
7. Pregnant or breast-feeding women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 2 patient groups

ERAS group

Experimental group

Description:

Patients will undergo the ERAS programs.

Treatment:

Procedure: ERAS group

SC group

Other group

Description:

Patients will undergo the SC group.

Treatment:

Procedure: SC group