Uncut Roux-en-Y Gastrojejunostomy for Early Gastric Cancer Patients
The Effect of Uncut Roux-en-Y Gastrojejunostomy on Quality of Life After Laparoscopic Distal Gastrectomy for Early Gastric Cancer Patients
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 gastric-cancer
Started Feb 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 30, 2015
CompletedFirst Posted
Study publicly available on registry
December 31, 2015
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedAugust 11, 2016
August 1, 2016
2 years
December 30, 2015
August 10, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Quality of life
one year
Secondary Outcomes (1)
Complications
one year
Study Arms (2)
Conventional Roux-en-Y anastomosis
OTHERConventional Roux-en-Y Gastrojejunostomy will be used after laparoscopic distal gastrectomy for early gastric cancer.
Uncut Roux-en-Y anastomosis
EXPERIMENTALUncut Roux-en-Y Gastrojejunostomy will be used after laparoscopic distal gastrectomy for early gastric cancer.
Interventions
Conventional Roux-en-Y Gastrojejunostomy after laparoscopic distal gastrectomy for early gastric cancer patients
Uncut Roux-en-Y Gastrojejunostomy after laparoscopic distal gastrectomy for early gastric cancer patients
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029, China
Related Publications (2)
Cai Z, Mu M, Ma Q, Liu C, Jiang Z, Liu B, Ji G, Zhang B. Uncut Roux-en-Y reconstruction after distal gastrectomy for gastric cancer. Cochrane Database Syst Rev. 2024 Feb 29;2(2):CD015014. doi: 10.1002/14651858.CD015014.pub2.
PMID: 38421211DERIVEDXu H, Yang L, Zhang DC, Li Z, Li QY, Wang LJ, Li FY, Wang WZ, Xia YW, Xu ZK. To cut or not to cut? A prospective randomized controlled trial on short-term outcomes of the uncut Roux-en-Y reconstruction for gastric cancer. Surg Endosc. 2023 Aug;37(8):6172-6184. doi: 10.1007/s00464-023-10067-0. Epub 2023 May 9.
PMID: 37160808DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zekuan Xu, Professor
The First Affiliated Hospital with Nanjing Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the Department of General Surgery
Study Record Dates
First Submitted
December 30, 2015
First Posted
December 31, 2015
Study Start
February 1, 2016
Primary Completion
February 1, 2018
Study Completion
February 1, 2019
Last Updated
August 11, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will share
Data will be open access.