Uncut Roux-en-y Anastomosis Reduce Postoperative Complication and Improve Nutritional Status After Distal Gastrectomy

July 18, 2017 updated by: Sixth Affiliated Hospital, Sun Yat-sen University
The investigators intend to conduct multi-center randomized controlled study to find if Uncut Roux-en-Y anastomosis to the distal gastric cancer patients after radical D2 can reduce the long-term complications, affect the quality of life, and improve the prognosis, comparing to Billroth II anastomosis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

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

Gastric cancer is still one of the most common malignant tumors, and gastric antrum cancer is still common. Radical surgery is the only way to treat gastric antrum cancer, surgical procedures and reconstruction are closely related with the prognosis and quality of life, the choice is crucial. Gastrojejunostomy after distal gastrectomy may affect the quality of radical surgery, and postoperative diet, nutritional status and quality of life. More and more centers tend to choose Billroth II anastomosis, but patients prone to have a variety of complications, including reflux gastritis and bile reflux, malnutrition, seriously affecting the quality of life and so on. According to preliminary pilot study found that, uncut Roux-en-Y anastomosis way can keep the continuity of nerve-muscle function of the reconstruction of digestive tract, and closes the input in order to reduce the incidence of reflux, for improving the nutritional status and reducing complications and improve quality of life. Therefore, the investigators intend to conduct multi-center randomized controlled study to find if Uncut Roux-en-Y anastomosis to the distal gastric cancer patients after radical D2 can reduce the long-term complications, affect the quality of life, and improve the prognosis.

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 (Anticipated)

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.
832

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.
  • Phase 3

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Shi Chen, Ph.D
  • Phone Number: +862038254092
  • Email: cscp@163.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510655
        • Recruiting
        • The sixth affliated hospital of Sun Yat-sen University
        • Contact:
        • Contact:
          • Shi Chen, Ph.D
          • Phone Number: +862038254092
          • Email: cscp@163.com

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. pathological diagnosed as the gastric carcinoma, the possibility of removal by the surgeon and imaging physician assessment.
  2. no previous history of other malignancies combined.
  3. patients have signed informed consent;
  4. aged 18 to 80 years old, male or female patients;
  5. cardiopulmonary, liver and kidney function was normal, ECOG physical status score of 0 to 1 (see Appendix);
  6. the clinician determine the patient does not need emergency surgery;

Exclusion Criteria:

  1. pregnant or lactating women;
  2. the liver, lung, bone, and other distant metastasis;
  3. supraclavicular lymph nodes, pelvic or ovarian species, peritoneal dissemination, etc;
  4. a large number of ascites, cachexia;
  5. suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, poorly controlled hypertension merger, diabetes patients;
  6. or mental illness;
  7. 4 weeks prior to enrollment participated or are participating in other clinical trials of patients;
  8. had undergone surgery, and its influence has not been eliminated in the patient;
  9. of the stomach or esophagus history of malignancy, including stromal tumor, sarcoma, lymphoma, carcinoid;
  10. patients with active infection (infection causing fever above 38 ℃);
  11. patients with poor compliance or researchers consider poor patient compliance;
  12. There are other clinical researchers believe that the laboratory the patient should not participate in the trial.

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: Prevention
  • 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: uncut Roux-en-Y anastomosis
After distal gastrectomy, duodenal stump closure, side to side anastomosis was underwent on the remnant stomach and jejunum,which was 25cm from Treitz ligament. Then underwent side to side anastomosis between jejunum about 35cm distance from gastrojejunostomy and jejunum about 5cm from Triez ligament . close the intestinal cavity on the input less than 5cm distance from the loop gastrojejunostomy anastomosis by using uncut Closure devices
Procedure: Uncut Roux-en-Y anastomosis
Uncut Closure devices would be used to close the intestinal cavity on the input less than 5cm distance from the loop gastrojejunostomy anastomosis.
Sham Comparator: Billroth II anastomosis
After distal gastrectomy, duodenal stump closure, the investigators first underwent remnant stomach and upper jejunum side anastomosis. Then choose the jejunum about 25cm from Treitz ligament, premenstrual colon using a disposable cutting closure (or tubular stapling) in the rear wall of the stomach and jejunum anastomosis, common opening was closed with the (barbed wire) hand-stitched. After that, steps were same with the group A.
Procedure: Billroth II anastomosis
Typical Billroth II anastomosis would be made after the Distal gastrectomy.

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
Time Frame
Number of participants with treatment-related gastrointestinal and gastroesophageal reflux as assessed by The Los Angeles and Savary-Miller systems for grading esophagitis
Time Frame: 0-5 years
0-5 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.
Sixth Affiliated Hospital, Sun Yat-sen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jun-Sheng Peng, Ph.D, The sixth affliated hospital of Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

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.
September 1, 2016

Primary Completion (Anticipated)

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.
December 1, 2019

Study Completion (Anticipated)

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, 2020

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).
February 5, 2016

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.
May 4, 2016

First Posted (Estimate)

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.
May 5, 2016

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 21, 2017

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.
July 18, 2017

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, 2017

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.
  • CSGC-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigators would like to share the data to the Participating units.

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.

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