Oesophageal CancerNCT03658837
Gastrointestinal Functional Outcome Ivor Lewis
An observational study of Oesophageal Cancer, run by University Hospitals, Leicester at 1 site in United Kingdom.
Trial summary
This study focuses on the prevalence of functional complications and their impact on QOL in patients who underwent an Ivor Lewis Oesophagectomy. This study will assess the prevalence of gastrointestinal symptoms and QOL from beyond the first year following surgery up to 5 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oesophageal Cancer
- What is being tested?
- Ivor Lewis Oesophagectomy
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Jan 2019to 1 Dec 2019
- How long will I take part?
- 12 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient who underwent Ivor Lewis oesophagectomy with lymphadenectomy for oesophageal cancer will be selected from our database at the Department of Surgery, Leicester Royal Infirmary. These include patients from Leicestershire and Northamptonshire treated at the Leicester Royal Infirmary. Mid to long term survivors operated in our institution with a follow up of at least 12 months will be identified from our database to be included in our study.
Who may be able to join
- Patients who underwent Ivor Lewis Oesophagectomy in Leicester Royal Infirmary with minimum follow up of 12 months.
- Age more than 18
Who cannot join
- Disease recurrence within the follow up period
- Age less than 18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Outcome Following Ivor-Lewis Oesophagectomy
This study focuses on the prevalence of functional complications and their impact on QOL in patients who underwent an Ivor Lewis Oesophagectomy.
This study will assess the prevalence of gastrointestinal symptoms and QOL from beyond the first year following surgery up to 5 years. The aim is to determine whether gastrointestinal side effects and QOL are compromised in the long-term.
This study will also explore in details, the impact of surgery on their quality of life and gastro intestinal symptoms that patients has experienced post operatively.
Read the detailed description
Oesophago-gastric (OG) cancer is the fifth most common malignancy in the United Kingdom, affecting approximately 16,000 people each year. Although surgery offers the best prospect for potential cure of OG cancers, radical treatment may result in increased treatment relate mortality, high treatment-induced morbidity, and reduced quality of life. Traditionally, many centres managing OG cancers focused on mortality and morbidity as their key outcome measures. However, a growing body of opinion considers that a measure of broader effects of ill health and treatment on the patients quality of life (QOL) is necessary. Such considerations are important as it is questionable if patients are subjected to treatment merely to offer them a few extra months of life, particularly if this is at the expense of quality of life. These includes physical, functional, social and physiological aspects of life.
More than half of the operated patients will develop significant functional disorder after surgery affecting QOL. The most common problems observed are dysphagia, dumping syndrome, delayed gastric emptying, and reflux. These functional disorder are not always detected immediately post operatively, but may become more troublesome as time goes by.
The purpose of this study is
- to evaluate mid to long term HRQL in patients that underwent Ivor Lewis esophagectomy (ILE) with gastric pull-up in Royal Leicester Infirmary with minimum of 12 months follow up and up to 5 years.
- to identify clinical factors influencing quality of life post operatively.
- explore patients' experiences of their quality of life and how they handle their new life situation from a long-term perspective after oesophagectomy The outcome of this study would benefit both surgeons and patients in terms of pre-operative counselling and planning.
- Conditions
- Oesophageal Cancer
- Being tested
- Ivor Lewis Oesophagectomy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivor Lewis OesophagectomyProcedure or surgery
Patients who underwent Ivor-Lewis Oesophagectomy for cancer of oesophagus
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative Assessment using EORTC QLQ-C30 (version 3.0)
The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale.
All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL,but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Measured: Beyond 12 months up to 5 years
Quantitative Assessment using EORTC QLQ-OES-24
EORTC QLQ-OES-24 is a 24-item esophageal cancer-specific questionnaire supplementing EORTC QLQ-C30 with information about disease and treatment-related symptoms and side effects, dysphagia, nutrition, and social and emotional effects of esophageal cancer.
Scale scores will be calculated by averaging items within scales and transforming average scores linearly. All of the scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems
Measured: Beyond 12 months up to 5 years
Secondary outcomes (1)
Qualitative analysis
Interviews will be conducted with up to 15 participants and their carers and qualitative analysis of interviews will be performed
Measured: Beyond 12 months up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start3 Jan 2019
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oesophageal CancerStudies of the same condition, open and under way.
- 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
- 75 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University Hospitals, Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DAVID J BOWREY, MD, Study director, University Hospitals, Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658837
- Sponsor's protocol ID
- EDGE ID 107692
- Status last verified
- Dec 2023
- First submitted
- 13 Jul 2018
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcome Following Ivor-Lewis Oesophagectomy
- ClinicalTrials.gov ID
- NCT03658837
- Acronym / sponsor ID
- EDGE ID 107692
- Conditions
- Oesophageal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 5 Sep 2018 (actual)
- 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 focuses on the prevalence of functional complications and their impact on QOL in patients who underwent an Ivor Lewis Oesophagectomy.
This study will assess the prevalence of gastrointestinal symptoms and QOL from beyond the first year following surgery up to 5 years. The aim is to determine whether gastrointestinal side effects and QOL are compromised in the long-term.
This study will also explore in details, the impact of surgery on their quality of life and gastro intestinal symptoms that patients has experienced post operatively.
Detailed description
Oesophago-gastric (OG) cancer is the fifth most common malignancy in the United Kingdom, affecting approximately 16,000 people each year. Although surgery offers the best prospect for potential cure of OG cancers, radical treatment may result in increased treatment relate mortality, high treatment-induced morbidity, and reduced quality of life. Traditionally, many centres managing OG cancers focused on mortality and morbidity as their key outcome measures. However, a growing body of opinion considers that a measure of broader effects of ill health and treatment on the patients quality of life (QOL) is necessary. Such considerations are important as it is questionable if patients are subjected to treatment merely to offer them a few extra months of life, particularly if this is at the expense of quality of life. These includes physical, functional, social and physiological aspects of life.
More than half of the operated patients will develop significant functional disorder after surgery affecting QOL. The most common problems observed are dysphagia, dumping syndrome, delayed gastric emptying, and reflux. These functional disorder are not always detected immediately post operatively, but may become more troublesome as time goes by.
The purpose of this study is
- to evaluate mid to long term HRQL in patients that underwent Ivor Lewis esophagectomy (ILE) with gastric pull-up in Royal Leicester Infirmary with minimum of 12 months follow up and up to 5 years.
- to identify clinical factors influencing quality of life post operatively.
- explore patients' experiences of their quality of life and how they handle their new life situation from a long-term perspective after oesophagectomy The outcome of this study would benefit both surgeons and patients in terms of pre-operative counselling and planning.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who underwent Ivor Lewis oesophagectomy with lymphadenectomy for oesophageal cancer will be selected from our database at the Department of Surgery, Leicester Royal Infirmary. These include patients from Leicestershire and Northamptonshire treated at the Leicester Royal Infirmary. Mid to long term survivors operated in our institution with a follow up of at least 12 months will be identified from our database to be included in our study.
Key inclusion criteria (2 listed)
- Patients who underwent Ivor Lewis Oesophagectomy in Leicester Royal Infirmary with minimum follow up of 12 months.
- Age more than 18
Key exclusion criteria (2 listed)
- Disease recurrence within the follow up period
- Age less than 18
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 |
|---|---|---|
| Ivor Lewis OesophagectomyPatients who underwent Ivor-Lewis Oesophagectomy for cancer of oesophagus | Procedure or surgery | – |
Primary outcome
Quantitative Assessment using EORTC QLQ-C30 (version 3.0)
Time frame: Beyond 12 months up to 5 years
The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL,but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Quantitative Assessment using EORTC QLQ-OES-24
Time frame: Beyond 12 months up to 5 years
EORTC QLQ-OES-24 is a 24-item esophageal cancer-specific questionnaire supplementing EORTC QLQ-C30 with information about disease and treatment-related symptoms and side effects, dysphagia, nutrition, and social and emotional effects of esophageal cancer. Scale scores will be calculated by averaging items within scales and transforming average scores linearly. All of the scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems
1 secondary outcome
Qualitative analysis
Time frame: Beyond 12 months up to 5 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 12 Dec 2023.
- Individual participant dataSharing planned: No
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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.
DAVID J BOWREY, MD study director
University Hospitals, Leicester
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 Oesophageal Cancer, run by University Hospitals, Leicester at 1 site in United Kingdom.
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 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 12 Dec 2023. 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 Kingdom. 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?
Quantitative Assessment using EORTC QLQ-C30 (version 3.0) (time frame: Beyond 12 months up to 5 years). The study lists 2 primary outcomes in all. 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 12 Dec 2023.