Gastric TumorPhase 3GCQOL02NCT01697943
Impact of Roux-En-Y Pouch Reconstruction Compared With Conventional Roux-En-Y Reconstruction on Quality of Life in Patients Undergoing Total Gastrectomy
A Phase 3 study testing Roux-En-Y Pouch Reconstruction or Conventional Roux-En-Y Reconstruction in people with Gastric Tumor, run by Fudan University at 1 site in China.
Trial summary
The purpose of this study is to find out more about differences of the quality of life in patients undergoing Roux-En-Y pouch reconstruction and conventional Roux-En-Y reconstruction. To find a better reconstruction for patients who received total gastrectomy. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Gastric Tumor
- What is being tested?
- Roux-En-Y Pouch Reconstruction or Conventional Roux-En-Y Reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- May 2012to May 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Pathologically confirmed gastric malignant tumor at fUSCC (biopsy may be performed at other institutions but slides must be confirmed at SHCA, as is routine care at our institution) , and the patients be assessed must be carried out total gastrectomy by three specialists.
- Patients 20-75 years old
- Normal organ function, able to tolerate surgery, no clear contraindication for surgery
- No evidence of metastases of adjacent organs
- be able to provide follow-up over 2 years
- No specific treatment for gastric cancer before surgery
- In line with the Declaration of Helsinki and the requirements of the hospital ethics committee.
- The subjects were able to understand and comply with the trial protocol, and signed informed consent.
Who cannot join
- • Synchronous or metachronous (less than five years) and with other malignancies.
- Cirrhosis and portal hypertension
- Associated with blood diseases
- Serious heart/ lung and kidney dysfunction or with metabolic diseases such as diabetes, hyperthyroidism.
- Suffering from a serious neurological diseases or psychological diseases affecting the life
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Ya Nong Wang, MD,PhD, +86-21 64175590 ext. 1208, huahuang@fudan.edu.cn
Hua Huang, MD,PhD, +86-21 64175590 ext. 1205, huahuang@fudan.edu.cn
About this study
Official title: A Pilot Randomized Controlled Trial Examining the Differences of Quality of Life of Roux-En-Y Pouch Reconstruction and Conventional Roux-En-Y Reconstruction in Patients Undergoing Total Gastrectomy.
The purpose of this study is to find out more about differences of the quality of life in patients undergoing Roux-En-Y pouch reconstruction and conventional Roux-En-Y reconstruction. To find a better reconstruction for patients who received total gastrectomy.
Read the detailed description
Total gastrectomy has been indicated mainly for advanced gastric cancer located from the upper to middle third of the stomach or multiple gastric cancers.The most common method of creating a way for food is called a "Roux-en-Y", in which one part of the intestines is connected with the end of the esophagus (the swallowing tube) in the abdomen, and another connection is made between the intestines ' lower down.
Patients with total gastrectomy suffer from poor food intake, anemia, and poor digestion because of loss of gastric reservoir or a lack of normal hormonal secretion for digestion. It often is associated with a limitation of postoperative quality of life (QOL). To improve postoperative nutritional status and QOL, surgeons have tried to establish ideal reconstruction after total gastrectomy and the optimum procedure for reconstruction has been discussed.
This study will compare the postoperative quality of life (QOL) of gastric pouch reconstruction with the usual reconstruction to see if the pouch makes patients feel better.
- Conditions
- Gastric Tumor
- Being tested
- Roux-En-Y Pouch Reconstruction or Conventional Roux-En-Y Reconstruction
- Keywords
- Gastric Malignant Tumor, Total Gastrectomy, Reconstruction
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux-En-Y Pouch Reconstruction or Conventional Roux-En-Y ReconstructionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Roux-En-Y Pouch Reconstruction or Roux-En-Y Reconstruction | Experimental | Not described Receives: Procedure: Roux-En-Y Pouch Reconstruction or Conventional Roux-En-Y Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in QOL (Quality of Life)
From preoperative following total gastrectomy, as measured with the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-STO22 questionnaires
Measured: 5years
Secondary outcomes (1)
Nutritional status of patients
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2015 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric TumorStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanong Wang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01697943
- Sponsor's protocol ID
- 2012-44-563
- Acronym
- GCQOL02
- Status last verified
- Oct 2012
- First submitted
- 28 Sep 2012
- Last updated
- 16 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial Examining the Differences of Quality of Life of Roux-En-Y Pouch Reconstruction and Conventional Roux-En-Y Reconstruction in Patients Undergoing Total Gastrectomy.
- ClinicalTrials.gov ID
- NCT01697943
- Acronym / sponsor ID
- GCQOL02 / 2012-44-563
- Conditions
- Gastric Tumor
- Keywords
- Gastric Malignant Tumor, Total Gastrectomy, Reconstruction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 2 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out more about differences of the quality of life in patients undergoing Roux-En-Y pouch reconstruction and conventional Roux-En-Y reconstruction. To find a better reconstruction for patients who received total gastrectomy.
Detailed description
Total gastrectomy has been indicated mainly for advanced gastric cancer located from the upper to middle third of the stomach or multiple gastric cancers.The most common method of creating a way for food is called a "Roux-en-Y", in which one part of the intestines is connected with the end of the esophagus (the swallowing tube) in the abdomen, and another connection is made between the intestines ' lower down.
Patients with total gastrectomy suffer from poor food intake, anemia, and poor digestion because of loss of gastric reservoir or a lack of normal hormonal secretion for digestion. It often is associated with a limitation of postoperative quality of life (QOL). To improve postoperative nutritional status and QOL, surgeons have tried to establish ideal reconstruction after total gastrectomy and the optimum procedure for reconstruction has been discussed.
This study will compare the postoperative quality of life (QOL) of gastric pouch reconstruction with the usual reconstruction to see if the pouch makes patients feel better.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Roux-En-Y Pouch Reconstruction or Roux-En-Y Reconstruction | Experimental | Procedure: Roux-En-Y Pouch Reconstruction or Conventional Roux-En-Y Reconstruction |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- • Pathologically confirmed gastric malignant tumor at fUSCC (biopsy may be performed at other institutions but slides must be confirmed at SHCA, as is routine care at our institution) , and the patients be assessed must be carried out total gastrectomy by three specialists.
Key exclusion criteria (5 listed)
- • Synchronous or metachronous (less than five years) and with other malignancies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roux-En-Y Pouch Reconstruction or Conventional Roux-En-Y Reconstruction | Procedure or surgery | Roux-En-Y Pouch Reconstruction or Roux-En-Y Reconstruction |
Primary outcome
Change in QOL (Quality of Life)
Time frame: 5years
From preoperative following total gastrectomy, as measured with the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-STO22 questionnaires
1 secondary outcome
Nutritional status of patients
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Roux-En-Y Pouch Reconstruction or Conventional Roux-En-Y Reconstruction in people with Gastric Tumor, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ya Nong Wang, MD,PhD (+86-21 64175590 ext. 1208, huahuang@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in QOL (Quality of Life) (time frame: 5years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2012.