Anastomotic LeakNCT03203434
Non-invasive Detection of Anastomotic Leakage
An observational study of Anastomotic Leak, run by Amsterdam UMC, location VUmc.
Trial summary
Esophagectomy or pancreaticoduodenectomy is the standard surgical approach for patients with malignant tumors of the esophagus or pancreatic head. These procedures are associated with high morbidity rates, which are strongly correlated with the occurrence of anastomotic leakage. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Anastomotic Leak
- What is being tested?
- Urinary volatile organic compound analysis
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Mar 2017
- How long will I take part?
- 30 Days
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible participants had suspected malignancies of the esophagus, pancreas, distal bile duct, ampulla Vateri or duodenum and were scheduled for surgery (i.e. esophagectomy or pancreaticoduodenectomy).
Who may be able to join
- Patients were aged 18-90 years
- American Society of Anesthesiologists (ASA) physical status of 3 or lower
- All participants were capable to understand the study information and signed written informed consent
Who cannot join
- None
About this study
Official title: Non-invasive Detection of Anastomotic Leakage Following Esophageal and Pancreatic Surgery by Urinary Analysis
Esophagectomy or pancreaticoduodenectomy is the standard surgical approach for patients with malignant tumors of the esophagus or pancreatic head. These procedures are associated with high morbidity rates, which are strongly correlated with the occurrence of anastomotic leakage. Current diagnostic methods, including clinical, biochemical and radiological techniques are frequently inconclusive. Delay in diagnosis leads to delay in treatment, which ratifies the need for development of novel and accurate non-invasive diagnostic tests for detection of anastomotic leakage. Urinary volatile organic compounds reflect the metabolic status of an individual, which is associated with a systemic immunological response. The aim of this study was to determine the diagnostic accuracy of urinary volatile organic compounds to detect anastomotic leakage after esophagectomy or pancreaticoduodenectomy in an early phase.
- Conditions
- Anastomotic Leak
- Being tested
- Urinary volatile organic compound analysis
- Keywords
- Pancreatic cancer, Esophageal cancer, volatile organic compounds, Field asymmetric ion mobility spectrometry
- Medical subject headings
- Anastomotic Leak, Pancreatic Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urinary volatile organic compound analysisDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Esophageal anastomotic leakage | Not described Receives: Diagnostic Test: Urinary volatile organic compound analysis | |
| Esophageal uncomplicated controls | Not described Receives: Diagnostic Test: Urinary volatile organic compound analysis | |
| Pancreatic anastomotic leakage | Not described Receives: Diagnostic Test: Urinary volatile organic compound analysis | |
| Pancreatic uncomplicated controls | Not described Receives: Diagnostic Test: Urinary volatile organic compound analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic leakage
Measured: Postoperatively (30-days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start1 Jan 2015
- Primary completion1 Mar 2017
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anastomotic LeakStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe 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
- 66 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor Plat, Amsterdam UMC, location VUmc
- Investigators
- Freek Daams, MD PhD, Study director, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03203434
- Sponsor's protocol ID
- 2014.543
- Status last verified
- Jun 2017
- First submitted
- 27 Jun 2017
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- 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 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Detection of Anastomotic Leakage Following Esophageal and Pancreatic Surgery by Urinary Analysis
- ClinicalTrials.gov ID
- NCT03203434
- Acronym / sponsor ID
- 2014.543
- Conditions
- Anastomotic Leak
- Keywords
- Pancreatic cancer, Esophageal cancer, volatile organic compounds, Field asymmetric ion mobility spectrometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 29 Jun 2017 (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.
Esophagectomy or pancreaticoduodenectomy is the standard surgical approach for patients with malignant tumors of the esophagus or pancreatic head. These procedures are associated with high morbidity rates, which are strongly correlated with the occurrence of anastomotic leakage. Current diagnostic methods, including clinical, biochemical and radiological techniques are frequently inconclusive. Delay in diagnosis leads to delay in treatment, which ratifies the need for development of novel and accurate non-invasive diagnostic tests for detection of anastomotic leakage. Urinary volatile organic compounds reflect the metabolic status of an individual, which is associated with a systemic immunological response. The aim of this study was to determine the diagnostic accuracy of urinary volatile organic compounds to detect anastomotic leakage after esophagectomy or pancreaticoduodenectomy in an early phase.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Esophageal anastomotic leakage | – | Diagnostic Test: Urinary volatile organic compound analysis |
| Esophageal uncomplicated controls | – | Diagnostic Test: Urinary volatile organic compound analysis |
| Pancreatic anastomotic leakage | – | Diagnostic Test: Urinary volatile organic compound analysis |
| Pancreatic uncomplicated controls | – | Diagnostic Test: Urinary volatile organic compound analysis |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible participants had suspected malignancies of the esophagus, pancreas, distal bile duct, ampulla Vateri or duodenum and were scheduled for surgery (i.e. esophagectomy or pancreaticoduodenectomy).
Key inclusion criteria (3 listed)
- Patients were aged 18-90 years
- American Society of Anesthesiologists (ASA) physical status of 3 or lower
- All participants were capable to understand the study information and signed written informed consent
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Urinary volatile organic compound analysis | Diagnostic test | Esophageal anastomotic leakage, Esophageal uncomplicated controls, Pancreatic anastomotic leakage, Pancreatic uncomplicated controls |
Primary outcome
Anastomotic leakage
Time frame: Postoperatively (30-days)
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 2 Jul 2017.
- Individual participant dataSharing planned: No
Related trials for Anastomotic Leak
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Pre-emptive Endoscopic Vacuum Therapy Reduces the Incidence of Anastomotic Leakage After Colorectal Cancer Surgery
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Not yet recruiting
FLuorescent Angiography in REduction of Anastomotic Leak in Rectal Cancer Surgery
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RecruitingObservational study
Surgical Intuition in Anastomotic Leakage After Colorectal Surgery
Anastomotic Leaks
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.
Freek Daams, MD PhD study director
Amsterdam UMC, location VUmc
Questions about this trial
What is this clinical trial studying?
An observational study of Anastomotic Leak, run by Amsterdam UMC, location VUmc.
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 3 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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Anastomotic leakage (time frame: Postoperatively (30-days)). 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 2 Jul 2017.