Esophageal CancerNCT00642525
Detection of Anastomotic Leakage After Esophageal Surgery
A study testing Contrast swallow radiography, endoscopy in people with Esophageal Cancer and Anastomotic Leakage, run by Heidelberg University at 1 site in Germany.
Trial summary
Anastomotic leakage is a major complication in esophageal surgery. Although contrast swallow is the current standard to exclude anastomotic leakage postoperatively, endoscopy may be superior. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Anastomotic Leakage
- What is being tested?
- Contrast swallow radiography, endoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2006to Oct 2007
- Phase
- Interventional
- 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
- Patients with primary esophageal cancer undergoing transthoracic esophagectomy.
Who cannot join
- no transthoracic resection
- no primary anastomosis
- recurrent disease
- refusal to participate
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Surgery, University of Heidelberg
Heidelberg, 69120
About this study
Official title: Radiologic vs. Endoscopic Evaluation of the Conduit After Esophageal Resection: a Prospective, Blinded, Intraindividual Controlled Diagnostic Study.
Anastomotic leakage is a major complication in esophageal surgery. Although contrast swallow is the current standard to exclude anastomotic leakage postoperatively, endoscopy may be superior. This is the first study to compare radiographic contrast study and endoscopy for the identification of local complications after subtotal esophagectomy.
Read the detailed description
This prospective, blinded, intraindividual controlled study will be conducted with patients with transthoracic esophagectomy due to esophageal cancer. A radiographic contrast study will be performed prior to endoscopy at the 5th to 7th postoperative day. The investigators will not be aware of the results of the corresponding examination. Sensitivity, specificity and feasibility of the radiologic and endoscopic evaluation of the esophageal substitute will be compared.
- Conditions
- Esophageal Cancer, Anastomotic Leakage
- Being tested
- Contrast swallow radiography, endoscopy
- Keywords
- detection of anastomotic leakage, esophageal resection, diagnostic safety
- 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.
Contrast swallow radiography, endoscopyProcedure or surgery
Contrast swallow radiography is performed using water soluble contrast medium Esophagoscopy is performed according to standard safety guidelines
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | A prospective, blinded, intraindividual controlled study is conducted with patients with transthoracic esophagectomy due to esophageal cancer. A radiographic contrast study is performed prior to endoscopy at the 5th to 7th postoperative day. Receives: Procedure: Contrast swallow radiography, endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of anastomotic leakage
Measured: 5-7 days after surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2008 (estimated)
- Study startJan 2006
- Primary completionSep 2007
- Study completionOct 2007
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.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00642525
- Sponsor's protocol ID
- Endoray
- Status last verified
- Mar 2008
- First submitted
- 19 Mar 2008
- Last updated
- 25 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiologic vs. Endoscopic Evaluation of the Conduit After Esophageal Resection: a Prospective, Blinded, Intraindividual Controlled Diagnostic Study.
- ClinicalTrials.gov ID
- NCT00642525
- Acronym / sponsor ID
- Endoray
- Conditions
- Esophageal Cancer, Anastomotic Leakage
- Keywords
- detection of anastomotic leakage, esophageal resection, diagnostic safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 25 Mar 2008 (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.
Anastomotic leakage is a major complication in esophageal surgery. Although contrast swallow is the current standard to exclude anastomotic leakage postoperatively, endoscopy may be superior. This is the first study to compare radiographic contrast study and endoscopy for the identification of local complications after subtotal esophagectomy.
Detailed description
This prospective, blinded, intraindividual controlled study will be conducted with patients with transthoracic esophagectomy due to esophageal cancer. A radiographic contrast study will be performed prior to endoscopy at the 5th to 7th postoperative day. The investigators will not be aware of the results of the corresponding examination. Sensitivity, specificity and feasibility of the radiologic and endoscopic evaluation of the esophageal substitute will be compared.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: Contrast swallow radiography, endoscopyA prospective, blinded, intraindividual controlled study is conducted with patients with transthoracic esophagectomy due to esophageal cancer. A radiographic contrast study is performed prior to endoscopy at the 5th to 7th postoperative day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with primary esophageal cancer undergoing transthoracic esophagectomy.
Key exclusion criteria (4 listed)
- no transthoracic resection
- no primary anastomosis
- recurrent disease
- refusal to participate
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 |
|---|---|---|
| Contrast swallow radiography, endoscopyContrast swallow radiography is performed using water soluble contrast medium Esophagoscopy is performed according to standard safety guidelines | Procedure or surgery | A |
Primary outcome
Detection of anastomotic leakage
Time frame: 5-7 days after surgical procedure
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 25 Mar 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contrast swallow radiography, endoscopy in people with Esophageal Cancer and Anastomotic Leakage, run by Heidelberg University at 1 site in Germany.
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 1 inclusion and 4 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 25 Mar 2008. 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 Germany. 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?
Detection of anastomotic leakage (time frame: 5-7 days after surgical procedure). 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 25 Mar 2008.