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Impact of Gastric Tube Reconstruction Widths on Quality of Life for Esophagogastric Cancers

Primary Purpose

Stomach Neoplasms, Esophageal Neoplasms

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
esophagojejunostomy after total gastrectomy
Roux-en-Y gastrojejunostomy after subtotal gastrectomy
wide tube reconstruction after subtotal gastrectomy
narrow tube reconstruction after subtotal gastrectomy
Sponsored by
West China Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Neoplasms focused on measuring Cancer of the esophagogastric junction, Reconstruction of gastric tube, Quality of life, Width, Regurgitation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. pathologically confirmed esophagogastric cancers
  2. age between 18 to 80 years
  3. no evidence of metastasis of adjacent organs
  4. organs function well to tolerate surgery
  5. no special treatment before surgery
  6. informed consent was written

Exclusion Criteria:

  1. with other site tumor,simultaneously
  2. locally recurrent gastric or esophageal cancer
  3. had a history of malignant tumor within 5 years(except the skin cancer)
  4. pregnant or lactating women
  5. there was contraindication for operation
  6. discovery of metastasis in the operation
  7. with mental disorder

Sites / Locations

  • West China hospital, Sichuan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Gastrectomy and subtotal gastrectomy

Wide and narrow reconstruction tube

Arm Description

to compare the quality of life between esophagojejunostomy after total gastrectomy(TG group) and Roux-en-Y gastrojejunostomy after subtotal gastrectomy(SG group)

to 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

local recurrence
disease free survival
the time from operation to confirmed local recurrence, distant metastases, or death due to disease or treatment, whichever occurred first
metastatic rate
ratio of the patients with metastasis after the operation
overall survival
the fraction of the person from the operation the death,no matter the reason of the death.
short-term complication of the surgery
complication including pulmonary infection, bleeding and anastomotic leakage et al.

Full Information

First Posted
July 22, 2013
Last Updated
September 10, 2016
Sponsor
West China Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01911832
Brief Title
Impact of Gastric Tube Reconstruction Widths on Quality of Life for Esophagogastric Cancers
Official Title
Impact of Widths After Gastric Tube Reconstruction on Quality of Life for Patients With Esophagogastric Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
February 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
With the decreasing prevalence of gastric cancer, the incidence of cancer of the esophagogastric junction has rapidly risen in recent three decades, especially in North America and Europe. Despite the use of chemotherapy, its 5-year survival rate is still low (less than 30%) for cancer of the esophagogastric junction. Surgery still remains the optimum therapy for cancer of the esophagogastric junction. 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. For quality of life, no prospective trial provides evidence comparing the two approaches. With a complete clearance of lymph nodes, esophagojejunostomy after total gastrectomy brings high 5-year survival rate, and can decrease the rate of local recurrence. However, due to the whole gastrectomy, the patients often represent bile regurgitation which may induce pulmonary infection, regurgitation asthma and weight loss. Roux-en-Y gastrojejunostomy after subtotal gastrectomy reserve partial gastric body which was reconstructed into gastric tube. The remaining gastric body still peristalses and functions as well as a stomach. At the same time, the remaining gastric body keeps acid-secreting function which may induce acid regurgitation after surgery. For Roux-en-Y gastrojejunostomy after subtotal gastrectomy, the width of reconstruction gastric tube was a key factor to predicate prognosis, and it often ranges from 3 cm to 6 cm, without universal standard. Narrow gastric tube may lack enough blood supply, as a result, it increase the rate of anastomotic leakage. On the contrary, wide gastric tube takes up much thoracic capacity which may disturb the normal pulmonary and cardiovascular function. Tabira and his colleagues conduct a prospective trail that proves the width of gastric tube has no relevance to local blood supply, anastomotic leakage and postoperative nutrition, but the study lack enough patients which may increase bias. So, there is no reliable evidence to predict the quality of postoperative life. The prospective trail recruits patients with of cancer of the esophagogastric junction. And eligible patients were assigned into three groups: total gastrostomy group (TG group), wide gastric tube group (WG group) and narrow gastric tube group (NG group). Quality of life include integrated questionnaire of QLQ-STO22 and QLQ-C30 and related symptom relief was assessed as primary endpoint. And local recurrence, disease free survival, metastatic rate, overall survival and short-term complication of surgery were also observed as secondary endpoints.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms, Esophageal Neoplasms
Keywords
Cancer of the esophagogastric junction, Reconstruction of gastric tube, Quality of life, Width, Regurgitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gastrectomy and subtotal gastrectomy
Arm Type
Experimental
Arm Description
to compare the quality of life between esophagojejunostomy after total gastrectomy(TG group) and Roux-en-Y gastrojejunostomy after subtotal gastrectomy(SG group)
Arm Title
Wide and narrow reconstruction tube
Arm Type
Experimental
Arm Description
to 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
Intervention Type
Procedure
Intervention Name(s)
esophagojejunostomy after total gastrectomy
Other Intervention Name(s)
total gastrostomy group(TG group)
Intervention Type
Procedure
Intervention Name(s)
Roux-en-Y gastrojejunostomy after subtotal gastrectomy
Other Intervention Name(s)
subtotal gastrectomy(SG group)
Intervention Type
Procedure
Intervention Name(s)
wide tube reconstruction after subtotal gastrectomy
Other Intervention Name(s)
wide gastric tube group(WG group)
Intervention Type
Procedure
Intervention Name(s)
narrow tube reconstruction after subtotal gastrectomy
Other Intervention Name(s)
narrow gastric tube group(NG group)
Primary Outcome Measure Information:
Title
quality of life
Description
quality of life include: 1)integrated questionnaire of QLQ-STO22 and QLQ-C30. 2)related symptom relief of regurgitation, dysphagia and heartburn et al.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
local recurrence
Time Frame
1 year
Title
disease free survival
Description
the time from operation to confirmed local recurrence, distant metastases, or death due to disease or treatment, whichever occurred first
Time Frame
1 year
Title
metastatic rate
Description
ratio of the patients with metastasis after the operation
Time Frame
1 year
Title
overall survival
Description
the fraction of the person from the operation the death,no matter the reason of the death.
Time Frame
1 and 3 years
Title
short-term complication of the surgery
Description
complication including pulmonary infection, bleeding and anastomotic leakage et al.
Time Frame
first 30 day after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei M tian, M.D.
Phone
+8613198596090
Email
m.weihx@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Deng X bing, M.D.
Phone
+8613730677124
Email
xiangbingdeng@gmail.com
Facility Information:
Facility Name
West China hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Z qiang, PhD,MD
Phone
+8618980602028
Email
wzqtrial@gmail.com
First Name & Middle Initial & Last Name & Degree
Zhang Y chuan
Phone
+8613880412932
Email
20874185@qq.com
First Name & Middle Initial & Last Name & Degree
Zhang Bo, PhD,MD

12. IPD Sharing Statement

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PubMed Identifier
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Impact of Gastric Tube Reconstruction Widths on Quality of Life for Esophagogastric Cancers

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