ERAS in Totally Laparoscopic Total Gastrectomy for Gastric Cancer

June 28, 2024 updated by: Xijing Hospital

The Safety and Efficacy of ERAS Clinical Pathway Intotally Laparoscopic Total Gastrectomy: a Multicenter, Prospective Randomized Controlled Study

The number of totally laparoscopic total gastrectomy is gradually increasing, but the safety of ERAS in these term is still unknown and further multicenter randomized controlled studies are needed.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The application of ERAS during the perioperative of gastric cancer surgery can reduce hospitalization time, costs, and surgical stress response without increasing complications and readmission rates, and may even have a certain effect on improving long-term survival rates of patients. However, some studies have also shown that ERAS may increase the number of postoperative readmissions while reducing hospitalization time, costs, and recovery time after surgery. At the same time, there is still no consensus on the application standards of ERAS during the perioperative period of gastric cancer surgery , and the comprehensive implementation of ERAS programs in clinical practice still faces huge challenges. With the widespread development of totally laparoscopic total gastrectomy , the advantages of laparoscopy have been recognized. Multiple center studies have confirmed the safety of ERAS programs in totally laparoscopic distal radical gastrectomy. However, due to the complexity of totally laparoscopic total gastrectomy, there is currently no multi-center study to confirm the safety of ERAS in it. In order to better apply ERAS in clinical practice, better serve patients undergoing gastric cancer surgery, and provide more centers with practical experience in ERAS and even provide evidence for the establishment of a consensus on ERAS during the perioperative of gastric cancer surgery, our center will rely on platform advantages and previous work experience and collaborate with the CLASS Research Center to conduct a prospective, multi-center clinical study to explore the safety and effectiveness of ERAS clinical pathway in patients undergoing totally laparoscopic total gastrectomy, providing a theoretical basis for further standardizing and promoting the application of ERAS concept in the perioperative clinical practice of gastric cancer surgery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2656

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710000
        • Xijing Hospital of Digestive Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 18-80 years;
  2. ASA I-III;
  3. ECOG ≤2;
  4. NRS2002: 0-2;
  5. Preoperative gastroscopy and pathological biopsy confirmed adenocarcinoma;
  6. The clinical stage of abdominal hypotonic enhanced CT or ultrasonic gastroscopy is cT2-3N0-3M0 or cT1N+M0 or cT4aN0M0 (according to the AJCC-8thTNM tumor staging);
  7. Proposed D2 total laparoscopic radical gastrectomy (without limitation on the anastomotic method);
  8. All patients did not receive adjuvant radiotherapy, chemotherapy, or other cytotoxic treatments before surgery;
  9. Borrmann I-III ;
  10. No history of upper abdominal surgery (except for laparoscopic cholecystectomy); no history of peritonitis or pancreatitis
  11. hemoglobin ≥80g/L; absolute neutrophil count (ANC) ≥1.5×109/L; platelet ≥100×109/L; ALT, AST≤1 times the upper limit of normal; ALP≤1 times the upper limit of normal; total serum bilirubin <1.5 times the upper limit of normal; serum creatinine <1 times the upper limit of normal; serum albumin ≥35g/L;

Exclusion Criteria:

  1. tumors at the esophagogastric junction or gastric tumors that have invaded the pyloric canal;
  2. Those with uncontrolled epilepsy, central nervous system diseases, or a history of mental disorders;
  3. Severe (i.e., active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure, or severe drug-dependent arrhythmia, or a history of myocardial infarction within the last 6 months;
  4. Patients with urinary dysfunction who require long-term indwelling catheters after surgery;
  5. Patients who need immunosuppressive therapy for organ transplantation;
  6. Patients with severe uncontrolled recurrent infections or other severe uncontrolled concomitant diseases;
  7. Moderate or severe renal impairment [creatinine clearance equal to or lower than 50ml/min (calculated according to the Cockroft and Gault equation), or serum creatinine > upper limit of normal (ULN);
  8. Emergency surgery due to tumor emergencies (bleeding, perforation, obstruction);
  9. Pregnant or breastfeeding women;
  10. Previously diagnosed other tumors (excluding cervical cancer and cutaneous melanoma)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ERAS group
It is necessary to remove the urinary catheter before the patient awakens from anesthesia, drink water orally in the early postoperative period, and remove the drainage tube and nutrition tube in the early postoperative period
Other: ERAS protocol
The ERAS process mainly includes removing the urethral catheter before the recovery of anesthesia, removing the abdominal drainage tube within 3 days after surgery, removing the nasogastric feeding tu
Other: control group
According to conventional treatment measures, there is no need for Enhanced Recovery After Surgery
Other: ERAS protocol
The ERAS process mainly includes removing the urethral catheter before the recovery of anesthesia, removing the abdominal drainage tube within 3 days after surgery, removing the nasogastric feeding tu

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
QLQ-STO22
Time Frame: Changes in quality of life in QLQ-STO22 before surgery, on the 7th day after surgery, and 1 ,6,12month after surgery
Changes in quality of life in QLQ-STO22 before surgery, on the 7th day after surgery, and 1 ,6,12month after surgery
Changes in quality of life in QLQ-STO22 before surgery, on the 7th day after surgery, and 1 ,6,12month after surgery
QLQ-C30 (V3.0)
Time Frame: Changes in quality of life in QLQ-C30 (V3.0) before surgery, on the 7th day after surgery, and 1 ,6,12month after surgery
Changes in quality of life in QLQ-C30 (V3.0) before surgery, on the 7th day after surgery, and 1 ,6,12month after surgery
Changes in quality of life in QLQ-C30 (V3.0) before surgery, on the 7th day after surgery, and 1 ,6,12month after surgery
Complication rate
Time Frame: 1month
Complications rate and Clavien-Dindo classification within 1 month after surgery
1month
DFS
Time Frame: 1 and 3 years
Disease-free survival rate at 1 and 3 years after surgery
1 and 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xijing Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The First Affiliated Hospital with Nanjing Medical University
Fudan University
First Affiliated Hospital, Sun Yat-Sen University
Tongji Hospital
Peking University Cancer Hospital & Institute
First Affiliated Hospital Xi'an Jiaotong University
Guangdong Provincial People's Hospital
Gansu Provincial Hospital
Zhejiang University
First Hospital of China Medical University
General Hospital of Ningxia Medical University
First Affiliated Hospital of Wenzhou Medical University
Second Affiliated Hospital of Suzhou University
Changzhi People's Hospital
The Second Affiliated Hospital of Shandong First Medical University
Nanfang Hospital, Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLASS12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings