Impact of Gastric Tube Reconstruction Widths on Quality of Life for Esophagogastric Cancers
Impact of Widths After Gastric Tube Reconstruction on Quality of Life for Patients With Esophagogastric Cancers
1 other identifier
interventional
60
1 country
1
Brief Summary
The incidence of cancer of the esophagogastric junction has rapidly risen in recent three decades, and surgery still remains the optimum therapy. For Siewert's type II and III cancer, esophagojejunostomy after total gastrectomy and Roux-en-Y gastrojejunostomy after subtotal gastrectomy are regarded as the two main surgical approaches. Esophagojejunostomy after total gastrectomy brings high survival rate and low local recurrence rate which may also induces pulmonary infection or regurgitation. Roux-en-Y gastrojejunostomy after subtotal gastrectomy needs reconstruction of the gastric tube and the width of reconstruction tube was a key factor to predicate prognosis. However, no evidence supplies a comprehensive standard on the width of reconstruction tube which often ranges from 3 cm to 6 cm. Both narrow and wide reconstruction tubes have their own advantages and disadvantages. So the prospective trail recruits patients into three groups: total gastrostomy group (TG group), wide gastric tube group (WG group) and narrow gastric tube group (NG group). And the investigators compare the quality of life using integrated questionnaire of QLQ-STO22 and QLQ-C30 and related symptom relief as main endpoints.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2012
Longer than P75 for phase_3
1 active site
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
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 22, 2013
CompletedFirst Posted
Study publicly available on registry
July 30, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedSeptember 13, 2016
September 1, 2016
4.9 years
July 22, 2013
September 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
quality of life
quality of life include: 1)integrated questionnaire of QLQ-STO22 and QLQ-C30. 2)related symptom relief of regurgitation, dysphagia and heartburn et al.
3 years
Secondary Outcomes (5)
local recurrence
1 year
disease free survival
1 year
metastatic rate
1 year
overall survival
1 and 3 years
short-term complication of the surgery
first 30 day after operation
Study Arms (2)
Gastrectomy and subtotal gastrectomy
EXPERIMENTALto compare the quality of life between esophagojejunostomy after total gastrectomy(TG group) and Roux-en-Y gastrojejunostomy after subtotal gastrectomy(SG group)
Wide and narrow reconstruction tube
EXPERIMENTALto compare the quality of life between wide tube reconstruction after subtotal gastrectomy(WG group) and narrow tube reconstruction after subtotal gastrectomy(NG group) in Roux-en-Y gastrojejunostomy
Interventions
Eligibility Criteria
You may qualify if:
- pathologically confirmed esophagogastric cancers
- age between 18 to 80 years
- no evidence of metastasis of adjacent organs
- organs function well to tolerate surgery
- no special treatment before surgery
- informed consent was written
You may not qualify if:
- with other site tumor,simultaneously
- locally recurrent gastric or esophageal cancer
- had a history of malignant tumor within 5 years(except the skin cancer)
- pregnant or lactating women
- there was contraindication for operation
- discovery of metastasis in the operation
- with mental disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
West China hospital, Sichuan University
Chengdu, Sichuan, 610000, China
Related Publications (10)
Vial M, Grande L, Pera M. Epidemiology of adenocarcinoma of the esophagus, gastric cardia, and upper gastric third. Recent Results Cancer Res. 2010;182:1-17. doi: 10.1007/978-3-540-70579-6_1.
PMID: 20676867BACKGROUNDHasegawa S, Yoshikawa T. Adenocarcinoma of the esophagogastric junction: incidence, characteristics, and treatment strategies. Gastric Cancer. 2010 Jun;13(2):63-73. doi: 10.1007/s10120-010-0555-2. Epub 2010 Jul 3.
PMID: 20602191BACKGROUNDAllum WH, Stenning SP, Bancewicz J, Clark PI, Langley RE. Long-term results of a randomized trial of surgery with or without preoperative chemotherapy in esophageal cancer. J Clin Oncol. 2009 Oct 20;27(30):5062-7. doi: 10.1200/JCO.2009.22.2083. Epub 2009 Sep 21.
PMID: 19770374BACKGROUNDMariette C, Piessen G, Briez N, Gronnier C, Triboulet JP. Oesophagogastric junction adenocarcinoma: which therapeutic approach? Lancet Oncol. 2011 Mar;12(3):296-305. doi: 10.1016/S1470-2045(10)70125-X. Epub 2010 Nov 23.
PMID: 21109491BACKGROUNDJohansson J, Djerf P, Oberg S, Zilling T, von Holstein CS, Johnsson F, Walther B. Two different surgical approaches in the treatment of adenocarcinoma at the gastroesophageal junction. World J Surg. 2008 Jun;32(6):1013-20. doi: 10.1007/s00268-008-9470-7.
PMID: 18299921BACKGROUNDIelpo B, Pernaute AS, Elia S, Buonomo OC, Valladares LD, Aguirre EP, Petrella G, Garcia AT. Impact of number and site of lymph node invasion on survival of adenocarcinoma of esophagogastric junction. Interact Cardiovasc Thorac Surg. 2010 May;10(5):704-8. doi: 10.1510/icvts.2009.222778. Epub 2010 Feb 13.
PMID: 20154347BACKGROUNDDe Giacomo T, Francioni F, Venuta F, Trentino P, Moretti M, Rendina EA, Coloni GF. Complete mechanical cervical anastomosis using a narrow gastric tube after esophagectomy for cancer. Eur J Cardiothorac Surg. 2004 Nov;26(5):881-4. doi: 10.1016/j.ejcts.2004.07.024.
PMID: 15519175BACKGROUNDMatsuda T, Kaneda K, Takamatsu M, Takahashi M, Aishin K, Awazu M, Okamoto A, Kawaguchi K. Reliable preparation of the gastric tube for cervical esophagogastrostomy after esophagectomy for esophageal cancer. Am J Surg. 2010 May;199(5):e61-4. doi: 10.1016/j.amjsurg.2009.08.046. Epub 2010 Mar 3.
PMID: 20202621BACKGROUNDPierie JP, de Graaf PW, van Vroonhoven TJ, Obertop H. The vascularization of a gastric tube as a substitute for the esophagus is affected by its diameter. Dis Esophagus. 1998 Oct;11(4):231-5. doi: 10.1093/dote/11.4.231.
PMID: 10071804BACKGROUNDTabira Y, Sakaguchi T, Kuhara H, Teshima K, Tanaka M, Kawasuji M. The width of a gastric tube has no impact on outcome after esophagectomy. Am J Surg. 2004 Mar;187(3):417-21. doi: 10.1016/j.amjsurg.2003.12.008.
PMID: 15006575BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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 of the West China Hospital, Sichuan University
Study Record Dates
First Submitted
July 22, 2013
First Posted
July 30, 2013
Study Start
March 1, 2012
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
September 13, 2016
Record last verified: 2016-09