Gastric CancerPhase 3NCT01491698
Impact of Roux-En-Y Pouch Reconstruction Compared With Conventional Roux-En-Y Reconstruction on Health-Related Quality of Life in Patients Undergoing Total Gastrectomy for Adenocarcinoma
A Phase 3 study testing Roux-en-Y pouch reconstruction (RYP) and conventional Roux-en-Y reconstruction (RYC) in people with Gastric Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
This study is being done to learn more about how different surgery procedures bring back the eating pathway after removing the stomach in patients with stomach cancer. If the surgeon has decided that some, or all, of the patient's stomach must be removed the surgeon must create a new way to allow food to travel from… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Roux-en-Y pouch reconstruction (RYP) and conventional Roux-en-Y reconstruction (RYC)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Aug 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient 18 years of age or older
- Pathologically confirmed gastric adenocarcinoma at MSKCC (biopsy may be performed at other institutions but slides must be confirmed at MSKCC, as is routine care at our institution)
- No evidence of metastases(a)
- Total gastrectomy performed(b)
- Pouch reconstruction is technically feasible(c)
- Patients will be registered and consent obtained, if the surgeon believes there is no evidence of metastases. If metastatic disease is identified at the time of operation, the patient will not be randomized.
- Patients will be conditionally enrolled, and consent obtained, if the surgeon believes the patient may need a total gastrectomy at the time of operation. If a total gastrectomy is not performed, the patient will not be randomized.
- Patients will be excluded if, at the time of surgery, the surgeon feels that creation of a pouch is not technically feasible. This may be due to prior abdominal surgery, anatomic variants, or anything else at the surgeon's discretion.
Who cannot join
- Not expected to be able to provide follow-up over 2 years (due to geographic or other limitations)
- Not able to complete HRQOL instruments on their own (non-English speaking or physical status)
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Pilot Randomized Controlled Trial Examining the Impact of Roux-En-Y Pouch Reconstruction Compared With Conventional Roux-En-Y Reconstruction on Health-Related Quality of Life in Patients Undergoing Total Gastrectomy for Adenocarcinoma
This study is being done to learn more about how different surgery procedures bring back the eating pathway after removing the stomach in patients with stomach cancer. If the surgeon has decided that some, or all, of the patient's stomach must be removed the surgeon must create a new way to allow food to travel from the mouth to the intestines. Some patients develop problems because they are missing their stomach, such as lack of hunger, bloating, cramping, and heartburn.
The surgeons at Memorial Sloan-Kettering Cancer Center are conducting a study to determine if a change in surgery can help reduce these symptoms.
Read more
The most common method of creating a way for food is called a "Roux-en-Y", in which one part of the intestine is connected with the end of the esophagus (the swallowing tube) in the abdomen, and another connection is made between the intestines lower down.
The change in surgery involves creating a pouch from a part of the intestines to replace the stomach.
This study will compare the effects, good and/or bad, of gastric pouch reconstruction with the usual reconstruction to see if the pouch makes you feel better overall.
This type of surgery has been used by some surgeons for many years and is known to be safe, but it is not known if it reduces symptoms or improves nutrition compared with the usual surgery.
- Conditions
- Gastric Cancer
- Being tested
- Roux-en-Y pouch reconstruction (RYP), conventional Roux-en-Y reconstruction (RYC)
- Keywords
- stomach, surgery, Total Gastrectomy, Roux-En-Y Pouch Reconstruction, Conventional Roux-En-Y Reconstruction, Quality of Life, 11-170
- 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 (RYP)Procedure or surgery
Also called Patients will be seen in follow-up at intervals congruent with routine post-operative, care: post-operative (approximately 1 month), 3 months, 6 months, 12 months,, and 24 months following surgery (+- one month at each time interval to allow, flexibility in scheduling). At each of these visits patients will complete the
Patients will be consented to the study and complete pre-surgical questionnaires. Final randomization will occur once the surgeon in the operating room has confirmed eligibility intraoperatively. The envelope will be opened, and the patient randomized to either receive RYP or RYC. There are no restrictions on how surgeons may create the RYC or RYP reconstruction, except that the pouch must be a minimum of 15 cm in length (from esophago-jejunal anastomosis to end of jejuno-jejunal anastomosis).
conventional Roux-en-Y reconstruction (RYC)Procedure or surgery
Also called Patients will be seen in follow-up at intervals congruent with routine post-operative care:, post-operative (approximately 1 month), 3 months, 6 months, 12 months, and, 24 months following surgery (+- one month at each time interval to allow flexibility in scheduling). At each of these visits patients will complete the, HRQOL questionnaires, which require approximately 30 minutes total.
Patients will be consented to the study and complete pre-surgical questionnaires. Final randomization will occur once the surgeon in the operating room has confirmed eligibility intraoperatively. The envelope will be opened, and the patient randomized to either receive RYP or RYC. There are no restrictions on how surgeons may create the RYC or RYP reconstruction, except that the pouch must be a minimum of 15 cm in length (from esophago-jejunal anastomosis to end of jejuno-jejunal anastomosis).
| Study group | Role | What they receive |
|---|---|---|
| pts undergoing Roux-en-Y pouch reconstruction (RYP) | Experimental | This is a pilot randomized controlled trial comparing changes in health-related quality of life (HRQOL) in patients undergoing Roux-en-Y pouch reconstruction (RYP) with patients undergoing conventional Roux-en-Y reconstruction (RYC) following total gastrectomy for adenocarcinoma. Receives: Procedure: Roux-en-Y pouch reconstruction (RYP) |
| pts undergoing conventional Roux-en-Y reconstruction (RYC) | Active comparator | This is a pilot randomized controlled trial comparing change in health-related quality of life (HRQOL) in patients undergoing Roux-en-Y pouch reconstruction (RYP) with patients undergoing conventional Roux-en-Y reconstruction (RYC) following total gastrectomy for adenocarcinoma. Receives: Procedure: conventional Roux-en-Y reconstruction (RYC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility
of recruiting patients with gastric adenocarcinoma to this randomized controlled trial (RCT). We will assess this based on the number of patients who are randomized during the pilot study.
Measured: 2 years
Secondary outcomes (1)
change in HRQOL ( Health-Related 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: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Coit, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01491698
- Sponsor's protocol ID
- 11-070
- Status last verified
- Aug 2013
- First submitted
- 9 Dec 2011
- Last updated
- 15 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial Examining the Impact of Roux-En-Y Pouch Reconstruction Compared With Conventional Roux-En-Y Reconstruction on Health-Related Quality of Life in Patients Undergoing Total Gastrectomy for Adenocarcinoma
- ClinicalTrials.gov ID
- NCT01491698
- Acronym / sponsor ID
- 11-070
- Conditions
- Gastric Cancer
- Keywords
- stomach, surgery, Total Gastrectomy, Roux-En-Y Pouch Reconstruction, Conventional Roux-En-Y Reconstruction, Quality of Life, 11-170
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University, McMaster University
- Study start
- Dec 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 14 Dec 2011 (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.
This study is being done to learn more about how different surgery procedures bring back the eating pathway after removing the stomach in patients with stomach cancer. If the surgeon has decided that some, or all, of the patient's stomach must be removed the surgeon must create a new way to allow food to travel from the mouth to the intestines. Some patients develop problems because they are missing their stomach, such as lack of hunger, bloating, cramping, and heartburn.
The surgeons at Memorial Sloan-Kettering Cancer Center are conducting a study to determine if a change in surgery can help reduce these symptoms.
The most common method of creating a way for food is called a "Roux-en-Y", in which one part of the intestine is connected with the end of the esophagus (the swallowing tube) in the abdomen, and another connection is made between the intestines lower down.
The change in surgery involves creating a pouch from a part of the intestines to replace the stomach.
This study will compare the effects, good and/or bad, of gastric pouch reconstruction with the usual reconstruction to see if the pouch makes you feel better overall.
This type of surgery has been used by some surgeons for many years and is known to be safe, but it is not known if it reduces symptoms or improves nutrition compared with the usual surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pts undergoing Roux-en-Y pouch reconstruction (RYP) | Experimental | Procedure: Roux-en-Y pouch reconstruction (RYP)This is a pilot randomized controlled trial comparing changes in health-related quality of life (HRQOL) in patients undergoing Roux-en-Y pouch reconstruction (RYP) with patients undergoing conventional Roux-en-Y reconstruction (RYC) following total gastrectomy for adenocarcinoma. |
| pts undergoing conventional Roux-en-Y reconstruction (RYC) | Active comparator | Procedure: conventional Roux-en-Y reconstruction (RYC)This is a pilot randomized controlled trial comparing change in health-related quality of life (HRQOL) in patients undergoing Roux-en-Y pouch reconstruction (RYP) with patients undergoing conventional Roux-en-Y reconstruction (RYC) following total gastrectomy for adenocarcinoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient 18 years of age or older
- Pathologically confirmed gastric adenocarcinoma at MSKCC (biopsy may be performed at other institutions but slides must be confirmed at MSKCC, as is routine care at our institution)
- No evidence of metastases(a)
- Total gastrectomy performed(b)
- Pouch reconstruction is technically feasible(c)
Key exclusion criteria (2 listed)
- Not expected to be able to provide follow-up over 2 years (due to geographic or other limitations)
- Not able to complete HRQOL instruments on their own (non-English speaking or physical status)
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 (RYP)Also: Patients will be seen in follow-up at intervals congruent with routine post-operative, care: post-operative (approximately 1 month), 3 months, 6 months, 12 months,, and 24 months following surgery (+- one month at each time interval to allow, flexibility in scheduling). At each of these visits patients will complete thePatients will be consented to the study and complete pre-surgical questionnaires. Final randomization will occur once the surgeon in the operating room has confirmed eligibility intraoperatively. The envelope will be opened, and the patient randomized to either receive RYP or RYC. There are no restrictions on how surgeons may create the RYC or RYP reconstruction, except that the pouch must be a minimum of 15 cm in length (from esophago-jejunal anastomosis to end of jejuno-jejunal anastomosis). | Procedure or surgery | pts undergoing Roux-en-Y pouch reconstruction (RYP) |
| conventional Roux-en-Y reconstruction (RYC)Also: Patients will be seen in follow-up at intervals congruent with routine post-operative care:, post-operative (approximately 1 month), 3 months, 6 months, 12 months, and, 24 months following surgery (+- one month at each time interval to allow flexibility in scheduling). At each of these visits patients will complete the, HRQOL questionnaires, which require approximately 30 minutes total.Patients will be consented to the study and complete pre-surgical questionnaires. Final randomization will occur once the surgeon in the operating room has confirmed eligibility intraoperatively. The envelope will be opened, and the patient randomized to either receive RYP or RYC. There are no restrictions on how surgeons may create the RYC or RYP reconstruction, except that the pouch must be a minimum of 15 cm in length (from esophago-jejunal anastomosis to end of jejuno-jejunal anastomosis). | Procedure or surgery | pts undergoing conventional Roux-en-Y reconstruction (RYC) |
Primary outcome
feasibility
Time frame: 2 years
of recruiting patients with gastric adenocarcinoma to this randomized controlled trial (RCT). We will assess this based on the number of patients who are randomized during the pilot study.
1 secondary outcome
change in HRQOL ( Health-Related Quality of Life)
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2013.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
Daniel Coit, MD principal investigator
Memorial Sloan Kettering Cancer Center
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 (RYP) and conventional Roux-en-Y reconstruction (RYC) in people with Gastric Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 15 Aug 2013. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feasibility (time frame: 2 years). 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 15 Aug 2013.