ERAS for Patients Received Neoadjuvant Chemotherapy

Gastric Cancer Clinical Trial

— ERASNAC  

Official title:

Enhanced Recovery After Surgery Programs for Patients Received Neoadjuvant Chemotherapy With Locally Advanced Gastric Cancer: a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03272984
• Other study ID #: 8150041701
• Status: Completed
• Phase: N/A
• First received: September 4, 2017
• Last updated: September 5, 2017
• Start date: April 1, 2015
• Est. completion date: July 6, 2017

Study information

• Verified date: September 2017
• Source: Jinling Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: July 6, 2017
• Est. primary completion date: June 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• ERAS group
ERAS is the name of a procedure. Patients in this group need receive the ERAS procedure instead of one drug.
• SC group
Patients were managed in accordance with SC programs during the perioperative period. SC programs were used daily in our center and were still routinely used in most of the other hospitals in China.

Locations

Country	Name	City	State
China	Jinling Hospital, Medical School of Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
JIANG Zhi-Wei

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative length of stay	Postoperative length of stay	1 month
Secondary	Postoperative complications	Postoperative complications	2 months
Secondary	The time to first flatus	Bowel recovery	1 week
Secondary	Time to semi-liquid diet	Bowel recovery	2 week