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

September 10, 2016 updated by: Ziqiang Wang,MD, West China Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zhang Bo, PhD,MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Gastrectomy and subtotal gastrectomy
to compare the quality of life between esophagojejunostomy after total gastrectomy(TG group) and Roux-en-Y gastrojejunostomy after subtotal gastrectomy(SG group)
Procedure: esophagojejunostomy after total gastrectomy
Other Names:
  • total gastrostomy group(TG group)
Procedure: Roux-en-Y gastrojejunostomy after subtotal gastrectomy
Other Names:
  • subtotal gastrectomy(SG group)
EXPERIMENTAL: Wide and narrow reconstruction tube
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
Procedure: wide tube reconstruction after subtotal gastrectomy
Other Names:
  • wide gastric tube group(WG group)
Procedure: narrow tube reconstruction after subtotal gastrectomy
Other Names:
  • narrow gastric tube group(NG group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life
Time Frame: 3 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
local recurrence
Time Frame: 1 year
1 year
disease free survival
Time Frame: 1 year
the time from operation to confirmed local recurrence, distant metastases, or death due to disease or treatment, whichever occurred first
1 year
metastatic rate
Time Frame: 1 year
ratio of the patients with metastasis after the operation
1 year
overall survival
Time Frame: 1 and 3 years
the fraction of the person from the operation the death,no matter the reason of the death.
1 and 3 years
short-term complication of the surgery
Time Frame: first 30 day after operation
complication including pulmonary infection, bleeding and anastomotic leakage et al.
first 30 day after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ANTICIPATED)

February 1, 2017

Study Completion (ANTICIPATED)

February 1, 2017

Study Registration Dates

First Submitted

July 22, 2013

First Submitted That Met QC Criteria

July 29, 2013

First Posted (ESTIMATE)

July 30, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

September 13, 2016

Last Update Submitted That Met QC Criteria

September 10, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WqLE-201324

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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