Roux-en-Y vs. Roux-en-Y+ Pouch for D2 Total Gastrectomy
WCGCC-1202
Jejunal Pouch for Postoperative Quality of Life Following Roux-en-Y Reconstruction of Radical Total Gastrectomy: a Multicenter Randomized Controlled Trial (WCGCC-1202)
1 other identifier
interventional
588
1 country
9
Brief Summary
Gastric is one of the most prevalence digestive malignance tumors in China. Radical resection of primary tumors and combine with dissection of regional lymph-nodes is acknowledged by surgeons all over the world. Nowadays, in order to improve the quality of life, controversies still exist to the reconstruction methods of total gastrectomy. Although roux-en-y anastomosis is the most common method adopted after total gastrectomy for it is an easily and safety method reconstruction method, but some problems still need us to solve, such as little food reserves, less food intake per meal and fast gastric emptying. These problems significantly affect the patients' quality of life after surgery. Roux-en-Y+Jejunal pouch anastomosis is newly born method can significant increase the volume to improve postoperative quality of life have been proven by some little sample size randomized control trail With the improvement of the gastric cancer surgery, this study proposed by prospective randomized controlled clinical trials aimed to comparing quality of life after traditional Roux-en-Y type and Roux-en-Y+ Jejunal pouch type anastomosis for radical total gastrectomy. Quality of life was evaluated according to the European Organization for Research and Treatment of Cancer (EORTC) Quality Of Life Questionnaire (QLQ)-C30 and QLQ-STO22. Quality of life will conducted in the 3 months, 6 months, 9 months, 12 months, 24 months, 36 months after gastrectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 gastric-cancer
Started Aug 2014
Longer than P75 for phase_3 gastric-cancer
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2014
CompletedFirst Posted
Study publicly available on registry
April 10, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedJanuary 24, 2018
January 1, 2018
5 years
April 7, 2014
January 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative quality of life
Postoperative quality of life is evaluated by the EORTC QLQ-C30 and the EORTC QLQ-STO22
3 years
Secondary Outcomes (3)
Intraoperative morbidity and mortality
Intraoperative
Postoperative morbidity and mortality
within the first 30 days after surgery
Change of the postoperative body weight
3 years
Study Arms (2)
Roux-en-Y+Pouch Group
EXPERIMENTALAbdominal approach D2 total gastrectomy with Roux-en-Y+Pouch anastomosis. Roux-en-Y+Pouch anastomosis: closed the stump of duodenum, cut off the jejunum from the 20cm of Treitz ligament, pouch reconstruction a J pouch with a length of 15 cm was constructed by connecting the 2 Jejunal lumina, œsophago-P type jejunum Storage bag anastomosis (duct-to-duct / duct-to-duct, before the colon/after the colon), jejunum - jejunum anastomosis (duct-to-duct / duct-to-duct), the distance between anastomotic were 40cm-60cm.
Roux-en-Y group
EXPERIMENTALAbdominal approach D2 total gastrectomy with Roux-en-Y anastomosis. Roux-en-Y anastomosis : closed the stump of duodenum, cut off the jejunum from the 20cm of Treitz ligament, œsophago-jejunal anastomosis (duct-to-duct / duct-to-duct, before the colon/after the colon), jejunum - jejunum anastomosis (duct-to-duct / duct-to-duct), the distance between anastomotic were 40cm-60cm
Interventions
Eligibility Criteria
You may qualify if:
- Preoperative endoscopy and biopsy confirmed gastric adenocarcinoma, and predictively feasible of total gastrectomy;
- Predictively resectable diseases, either early or locally advanced gastric cancer, of preoperative staging Japanese Gastric Cancer Association (JGCA) 14th Edition cT1N0M0-T4aN3M0, I-IIIb, except T4b;
- Age: 18-75 years;
- Without serious disease;
- WHO performance score \< 2;
- No limit to sexual and race;
- Informed consent required
You may not qualify if:
- Primary lesion cannot be resected in the pattern of transabdominal total gastrectomy, but for Whipple's procedure, or combined organ resection or with a transthoracic approach surgery;
- Patients with other gastric malignant diseases, such as lymphoma and stromal tumors etc.
- Patients suffering from malignant diseases before the study;
- Patients with other severe comorbidities and cannot tolerate surgery: such as severe heart and lung diseases, heart function below clinical stage 2, uncontrollable hypertension, pulmonary infection, moderate to severe chronic obstructive pulmonary disease (COPD), chronic bronchitis, severe diabetes and / or renal insufficiency, severe hepatitis and / or function below the rank of CHILD B grade, and severe malnutrition, etc.
- Performed emergency operation due to bleeding or perforation;
- Patients treated with neoadjuvant chemotherapy or radiation therapy which might affect the efficacy observation;
- Not the radical surgery, but with tumor residual (R1 or R2).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Southwest Hospital, the Third Military Medical University
Chongqing, Chongqing Municipality, 404100, China
Xinqiao Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 404100, China
First Affiliated Hospital of Lanzhou University
Lanzhou, Gansu, 730000, China
Union Hospital, Tongji Medical College
Wuhan, Hubei, 430000, China
First Affiliated Hospital of Xi'an Jiaotong University School of Medicine
Xian, Shanxi, 710000, China
Tangdu Hospital, Fourth Military Medical University
Xian, Shanxi, 710000, China
Xijing hospital, Fourth Military Medical University
Xian, Shanxi, 710000, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
First Affiliated Hospital of Kunming medical University
Kunming, Yunnan, 650000, China
Related Publications (1)
Hu J, Zhang W, Western China Gastric Cancer Collaboration C. [Experience and present situation of Western China Gastric Cancer Collaboration]. Zhonghua Wei Chang Wai Ke Za Zhi. 2017 Mar 25;20(3):247-250. Chinese.
PMID: 28338153DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jian-Kun Hu, M.D.
West China Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 7, 2014
First Posted
April 10, 2014
Study Start
August 1, 2014
Primary Completion
August 1, 2019
Study Completion
August 1, 2022
Last Updated
January 24, 2018
Record last verified: 2018-01