Uncut Roux-en-Y Gastrojejunostomy for Early Gastric Cancer Patients

August 10, 2016 updated by: Zekuan Xu, The First Affiliated Hospital with Nanjing Medical University

The Effect of Uncut Roux-en-Y Gastrojejunostomy on Quality of Life After Laparoscopic Distal Gastrectomy for Early Gastric Cancer Patients

The current commonly used for distal gastri cancer in gastrointestinal anastomosis is Roux-en-Y. However, the complications after Roux-en-Y reach an incidence of over 30% which involve nausea, vomiting, and abdominal distension. The underlying mechanism might be the result of interruption of intestine peristalsis. In 2013, Kim reported total laparoscopic uncut Roux-en-Y anastomosis could reduce Roux stasis syndrome incidence by keeping the continuity of jejunum. In September 2014, we carried out this operation in 30 cases in our centre. Our previous results showed that this operation had a low postoperative complication and short hospitalization time, indicating uncut Roux-en-Y anastomosis might be a safe procedure. However, some limitations are noticed. The report from South Korea is a retrospective study and the evaluation of QOL is certain subjective. Here, we aimed to perform the first randomized controlled clinical study on uncut Roux-en-Y anastomosis to improve QOL of patients after laparoscopic distal gastrectomy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The current commonly used for distal gastri cancer in gastrointestinal anastomosis is Roux-en-Y. However, the complications after Roux-en-Y reach an incidence of over 30% which involve nausea, vomiting, and abdominal distension. The underlying mechanism might be the result of interruption of intestine peristalsis. In 2013, Kim reported total laparoscopic uncut Roux-en-Y anastomosis could reduce Roux stasis syndrome incidence by keeping the continuity of jejunum. In September 2014, we carried out this operation in 30 cases in our centre. Our previous results showed that this operation had a low postoperative complication and short hospitalization time, indicating uncut Roux-en-Y anastomosis might be a safe procedure. However, some limitations are noticed. The report from South Korea is a retrospective study and the evaluation of QOL is certain subjective. Here, we aimed to perform the first randomized controlled clinical study on uncut Roux-en-Y anastomosis to improve QOL of patients after laparoscopic distal gastrectomy. The primary aim is to determine whether uncut Roux-en-Y anastomosis improve the quality of life of patients after laparoscopic distal gastrectomy.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 2

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

  • Name: Hao Xu, Doctor
  • Phone Number: 0086 13851530117
  • Email: hxu@njmu.edu.cn

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • The First Affiliated Hospital of Nanjing Medical University
        • Contact:

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

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Endoscopy and biopsy confirmed gastric antrum or angle (from the cardia more than 4cm) of gastric cancer
  • tumor stage: I
  • There is no experience with chemotherapy, no distant metastasis
  • Have their own ability to answer the questionnaire
  • There is no mental illness
  • Age between 18-70 years old
  • Agreed to participate in the experiment and signed informed consent

Exclusion Criteria:

  • pregnant or nursing patients
  • The combined more serious cardiovascular disease, liver and kidney dysfunction (glutamic-pyruvic transaminase/glutamic oxalacetic transaminase more than three times the upper limit of normal, serum creatinine more than 50% higher than the upper limit of normal), abnormal blood clotting function (mean prothrombin time, activated partial thromboplastin time higher than normal values above the upper limit of 50%), neuropsychiatric disorders
  • Patients with active infection
  • Have other malignant tumor
  • Some reason withdraw subjects, can not enrolled in the study again

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Conventional Roux-en-Y anastomosis
Conventional Roux-en-Y Gastrojejunostomy will be used after laparoscopic distal gastrectomy for early gastric cancer.
Procedure: Conventional Roux-en-Y Gastrojejunostomy
Conventional Roux-en-Y Gastrojejunostomy after laparoscopic distal gastrectomy for early gastric cancer patients
EXPERIMENTAL: Uncut Roux-en-Y anastomosis
Uncut Roux-en-Y Gastrojejunostomy will be used after laparoscopic distal gastrectomy for early gastric cancer.
Procedure: Uncut Roux-en-Y Gastrojejunostomy
Uncut Roux-en-Y Gastrojejunostomy after laparoscopic distal gastrectomy for early gastric cancer patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Complications
Time Frame: one year
one year

Collaborators and Investigators

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

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Investigators

  • Principal Investigator: Zekuan Xu, Professor, The First Affiliated Hospital with Nanjing 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

February 1, 2016

Primary Completion (ANTICIPATED)

February 1, 2018

Study Completion (ANTICIPATED)

February 1, 2019

Study Registration Dates

First Submitted

December 30, 2015

First Submitted That Met QC Criteria

December 30, 2015

First Posted (ESTIMATE)

December 31, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

August 11, 2016

Last Update Submitted That Met QC Criteria

August 10, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JSPH-0504

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be open access.

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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