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Completed

NCT Number: NCT03272984

ERAS for Patients Received Neoadjuvant Chemotherapy

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jinling Hospital, Medical School of Nanjing University

Nanjing, Jiangsu, 210002, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

ERAS group

Procedure

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

SC group

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.

Primary outcomes

  1. Postoperative length of stay

    Time frame: 1 month

    Postoperative length of stay

Secondary outcomes

  1. Postoperative complications

    Time frame: 2 months

    Postoperative complications

  2. The time to first flatus

    Time frame: 1 week

    Bowel recovery

  3. Time to semi-liquid diet

    Time frame: 2 week

    Bowel recovery

Sponsors and collaborators

Lead sponsor

JIANG Zhi-Wei

Other

Registry information

Official study title

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

Acronym: ERASNAC

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 6, 2017
Registry last updated
Sep 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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