Esophageal CancerNCT01551433
Tissue Oxygenation Are Associated With Anastomotic Leak Rates After an Ivor Lewis Esophagectomy
An observational study of Esophageal Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to test whether after an Ivor Lewis esophagectomy (the removal of a portion of the stomach and esophagus with re-attachment) there is an association between the intraoperative level of oxygen at the site where the esophagus is re-attached to the stomach (measured using the Wipox), and the… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- wireless pulse oximeter (Wipox)
- Type of treatment
- Medical device
- How many people
- 166 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Aug 2016
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The Thoracic Surgery clinics
Who may be able to join
- Patients who are scheduled to undergo an open or a minimally invasive Ivor Lewis esophagectomy
- > or = to 21 years of age
Who cannot join
- Patients who are not candidates for an esophagectomy as determined by the treating surgeon
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 Prospective Trial to Evaluate Whether Variations in Tissue Oxygenation Are Associated With Anastomotic Leak Rates After an Ivor Lewis Esophagectomy
The purpose of this study is to test whether after an Ivor Lewis esophagectomy (the removal of a portion of the stomach and esophagus with re-attachment) there is an association between the intraoperative level of oxygen at the site where the esophagus is re-attached to the stomach (measured using the Wipox), and the incidence of a disruption at the site of the attachment after the surgery.
- Conditions
- Esophageal Cancer
- Being tested
- wireless pulse oximeter (Wipox)
- Keywords
- esophagectomy, ESOPHAGUS, Wipox instrument, Tissue Oxygenation, Anastomotic Leak, 11-192
- Medical subject headings
- Esophageal Neoplasms, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wireless pulse oximeter (Wipox)Device
Also called Post-operatively, all complications will be recorded and graded by the RSA., Anastomotic leaks present either symptomatically or asymptomatically. An, asymptomatic leak is only detected on the routine post-operative esophagram on, post-operative days 5-7, and is isusally described as a 'contained leak'. A
In addition to the one Wipox measurement at the planned anastomotic site, the RSA will collect the systemic pulse oximeter reading, blood pressure, and heart rate at the time of the Wipox measurement. These measurements will be obtained as both internal controls of the accuracy of the Wipox (matching the Wipox pulse rate with the patient's), as well as additional variables to control for when assessing factors which might contribute to oxygen saturation at the anastomotic site. Pre-operative demographic information will be collected. This will include age, sex, any co-morbidities (cardiac, diabetes, respiratory), and use of pre-operative chemotherapy or chemo-radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Pts scheduled for Ivor Lewis esophagectomy | During the operation, once the gastric conduit has been mobilized and positioned, and once the anastomotic site has been identified by the surgeon, the assigned RSA will provide the Wipox instrument to the fellow (the primary surgeon will be blinded to the result) who will then obtain one measurement from the anastomotic site. Receives: Device: wireless pulse oximeter (Wipox) |
What is being measured
The primary outcome is the main question the study is designed to answer.
association between tissue oxygenation (measured using the Wipox) at the anastomotic site and the incidence of anastomotic leak after an Ivor Lewis esophagectomy.
The primary objective of this observational study is to determine whether in patients undergoing Ivor Lewis esophagectomy, low levels of tissue oxygenation at the anastomotic site are associated with increased risk of anastomotic leak (AL).
Measured: 2 years
Secondary outcomes (3)
To correlate various demographic
(age, co-morbidities, smoking history) and clinical variables (pre-operative therapy, intra-operative blood pressure and systemic oxygen saturation) with tissue oxygenation at the anastomotic site. Spearman rank correlation (for continuous variables) and Wilcoxon rank sum test (for categorical variables) will be used to test these associations.
Measured: 2 years
To correlate anastomotic site tissue oxygenation with the postdischarge incidence of stricture
the association between anastomotic site tissue oxygenation and the incidence of post-discharge stricture observed during the 6 months following surgery will be assessed using Wilcoxon rank sum test (with O2 levels on a continuous scale) and Fisher exact test.
Measured: 2 years
To correlate clinical variables
(age, co-morbidities, smoking history) and clinical variables (pre-operative therapy, intra-operative blood pressure and systemic oxygen saturation) with tissue oxygenation at the anastomotic site. Spearman rank correlation (for continuous variables) and Wilcoxon rank sum test (for categorical variables) will be used to test these associations.
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 posted12 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prasad Adusumilli, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01551433
- Sponsor's protocol ID
- 11-192
- Status last verified
- Aug 2016
- First submitted
- 1 Mar 2012
- Last updated
- 18 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial to Evaluate Whether Variations in Tissue Oxygenation Are Associated With Anastomotic Leak Rates After an Ivor Lewis Esophagectomy
- ClinicalTrials.gov ID
- NCT01551433
- Acronym / sponsor ID
- 11-192
- Conditions
- Esophageal Cancer
- Keywords
- esophagectomy, ESOPHAGUS, Wipox instrument, Tissue Oxygenation, Anastomotic Leak, 11-192
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 12 Mar 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 test whether after an Ivor Lewis esophagectomy (the removal of a portion of the stomach and esophagus with re-attachment) there is an association between the intraoperative level of oxygen at the site where the esophagus is re-attached to the stomach (measured using the Wipox), and the incidence of a disruption at the site of the attachment after the surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pts scheduled for Ivor Lewis esophagectomy | – | Device: wireless pulse oximeter (Wipox)During the operation, once the gastric conduit has been mobilized and positioned, and once the anastomotic site has been identified by the surgeon, the assigned RSA will provide the Wipox instrument to the fellow (the primary surgeon will be blinded to the result) who will then obtain one measurement from the anastomotic site. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The Thoracic Surgery clinics
Key inclusion criteria (2 listed)
- Patients who are scheduled to undergo an open or a minimally invasive Ivor Lewis esophagectomy
- > or = to 21 years of age
Key exclusion criteria (1 listed)
- Patients who are not candidates for an esophagectomy as determined by the treating surgeon
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 |
|---|---|---|
| wireless pulse oximeter (Wipox)Also: Post-operatively, all complications will be recorded and graded by the RSA., Anastomotic leaks present either symptomatically or asymptomatically. An, asymptomatic leak is only detected on the routine post-operative esophagram on, post-operative days 5-7, and is isusally described as a 'contained leak'. AIn addition to the one Wipox measurement at the planned anastomotic site, the RSA will collect the systemic pulse oximeter reading, blood pressure, and heart rate at the time of the Wipox measurement. These measurements will be obtained as both internal controls of the accuracy of the Wipox (matching the Wipox pulse rate with the patient's), as well as additional variables to control for when assessing factors which might contribute to oxygen saturation at the anastomotic site. Pre-operative demographic information will be collected. This will include age, sex, any co-morbidities (cardiac, diabetes, respiratory), and use of pre-operative chemotherapy or chemo-radiotherapy. | Device | Pts scheduled for Ivor Lewis esophagectomy |
Primary outcome
association between tissue oxygenation (measured using the Wipox) at the anastomotic site and the incidence of anastomotic leak after an Ivor Lewis esophagectomy.
Time frame: 2 years
The primary objective of this observational study is to determine whether in patients undergoing Ivor Lewis esophagectomy, low levels of tissue oxygenation at the anastomotic site are associated with increased risk of anastomotic leak (AL).
3 secondary outcomes
To correlate various demographic
Time frame: 2 years
To correlate anastomotic site tissue oxygenation with the postdischarge incidence of stricture
Time frame: 2 years
To correlate clinical variables
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 18 Aug 2016.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
Related trials for Esophageal Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
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.
Prasad Adusumilli, 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?
An observational study of Esophageal 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 2 inclusion and 1 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 18 Aug 2016. 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.
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?
association between tissue oxygenation (measured using the Wipox) at the anastomotic site and the incidence of anastomotic leak after an Ivor Lewis esophagectomy. (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 18 Aug 2016.