ERAS for Patients Received Neoadjuvant Chemotherapy

NCT ID: NCT03272984

Last Updated: 2017-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-01

Study Completion Date

2017-07-06

Brief Summary

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

Detailed Description

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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.

Conditions

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Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a parallel, open-label randomized controlled trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ERAS group

Patients will undergo the ERAS programs.

Group Type EXPERIMENTAL

ERAS group

Intervention Type PROCEDURE

ERAS is the name of a procedure. Patients in this group need receive the ERAS procedure instead of one drug.

SC group

Patients will undergo the SC group.

Group Type OTHER

SC group

Intervention Type PROCEDURE

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.

Interventions

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ERAS group

ERAS is the name of a procedure. Patients in this group need receive the ERAS procedure instead of one drug.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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JIANG Zhi-Wei

OTHER

Sponsor Role lead

Responsible Party

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JIANG Zhi-Wei

Vice director of Research Institute of General Surgery

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Zhiwei JIANG, MD

Role: PRINCIPAL_INVESTIGATOR

Jinling Hospital, Medical School of Nanjing University

Jian ZHAO, MD

Role: STUDY_DIRECTOR

Jinling Hospital, Medical School of Nanjing University

Locations

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Jinling Hospital, Medical School of Nanjing University

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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8150041701

Identifier Type: -

Identifier Source: org_study_id

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