ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02644148
Recruitment Status : Recruiting
First Posted : December 31, 2015
Last Update Posted : August 11, 2016
Sponsor:
Information provided by (Responsible Party):
Zekuan Xu, The First Affiliated Hospital with Nanjing Medical University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Procedure: Conventional Roux-en-Y Gastrojejunostomy Procedure: Uncut Roux-en-Y Gastrojejunostomy Phase 2

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  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of Uncut Roux-en-Y Gastrojejunostomy on Quality of Life After Laparoscopic Distal Gastrectomy for Early Gastric Cancer Patients
Study Start Date : February 2016
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Quality of life [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Complications [ Time Frame: one year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02644148


Contacts
Contact: Hao Xu, Doctor 0086 13851530117 hxu@njmu.edu.cn

Locations
China, Jiangsu
the First Affiliated Hospital of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Hao Xu, Doc.    0086 13851530117    66881866@qq.com   
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
Investigators
Principal Investigator: Zekuan Xu, Professor The First Affiliated Hospital with Nanjing Medical University

Responsible Party: Zekuan Xu, Director of the Department of General Surgery, The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT02644148     History of Changes
Other Study ID Numbers: JSPH-0504
First Posted: December 31, 2015    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be open access.

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases