Esophageal NeoplasmsLOCARENCT02676791
Influence of Esophageal Washout on Local Carcinoma Recurrence After Curative Resection
A study testing Povidone-Iodine in people with Esophageal Neoplasms, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
The LOCARE-Trial is an investigator initiated, randomized-controlled trial with two parallel arms (n=60 each) and investigates the influence of esophageal washout on long-term outcomes in patients undergoing elective esophageal resection for carcinoma. The primary endpoint is defined as local carcinoma recurrence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Neoplasms
- What is being tested?
- Povidone-Iodine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 16 Feb 2016to 24 Sep 2021
- 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 scheduled for elective esophageal resection or esophagectomy
- Age equal or greater than 18 years
- Written informed consent
- Squamous cell carcinoma of the esophagus (SCC)
- Adenocarcinoma of the gastroesophageal junction (AEG) Type I
Who cannot join
- Local irresectability or metastatic disease
- Adenocarcinoma of the gastroesophageal junction Type II and III
- Histopathological R1-resection
- Surgery for recurrence
- Iodine allergy
- Hyperthyreosis
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of GI, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden
Dresden
About this study
Official title: Influence of Esophageal Washout on Local Carcinoma Recurrence After Curative Resection - a Randomized Controlled Trial
The LOCARE-Trial is an investigator initiated, randomized-controlled trial with two parallel arms (n=60 each) and investigates the influence of esophageal washout on long-term outcomes in patients undergoing elective esophageal resection for carcinoma. The primary endpoint is defined as local carcinoma recurrence. Secondary endpoints will be locoregional and distant recurrence, disease-specific survival and esophageal cancer specific survival.
Read the detailed description
Treatment of squamous cell carcinoma and adenocarcinoma of the esophagus has changed rapidly over the last decades due to implementation of multimodal cancer therapies such as radiotherapy or combined radiochemotherapy. Surgery, however, still is the mainstay of curative treatment options for this cancer entity. Due to the significant improvement in surgical technique and perioperative management, the postoperative mortality rate has fallen to about 5% with an estimated 5-year survival of 35%. Nevertheless, patients after esophagectomy are at high risk for local recurrence especially within the first 2 years after treatment. Independent risk factors for the development of carcinoma recurrence are incomplete resection (R1), extracapsular lymph node involvement and postoperative complications. Exfoliated, malignant cells remaining in luminal organs like the esophagus or colorectum could present another important risk factor for local recurrence especially at the site of anastomosis. In the treatment of rectal cancer, data have shown, that intraoperative rectal washout significantly reduces the risk of local recurrence from about 10% to 5%. For this reason, rectal washout during anterior resection has become a standard in many surgical institutions. Besides agents like cetrimide, sodium hypochlorite, formalin or saline, povidone-iodine has also been used for rectal mucosal application in prospective studies. Questions arise, weather similar positive outcomes could be achieved in esophageal surgery. The investigators hypothesize that esophageal washout with a povidone-iodine solution (Betaisodona®, Mundipharma) reduces the risk of local carcinoma recurrence after radical resection.
- Conditions
- Esophageal Neoplasms
- Being tested
- Povidone-Iodine
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Povidone-IodineDrug
Also called Betaisodona
A standard nasogastric tube will be inserted into all patients after induction of general anesthesia. After surgical dissection, the esophagus / stomach will be cut at the desired level leaving the tip of the nasogastric tube proximal to the esophageal carcinoma. Then, 50ml of a 11% povidone-iodine solution (Betaisodona®, Mundipharma) will be introduced into the esophagus via the nasogastric tube and evacuated with a suction device (washout). The nasogastric tube will then be removed for completion of esophageal resection and beginning of reconstruction.
| Study group | Role | What they receive |
|---|---|---|
| A (Povidone-Iodine) | Experimental | Esophageal washout will be performed via a nasogastric tube with approx. 50ml of a 11% povidone-iodine solution (Betaisodona®, Mundipharma) during esophageal resection. Receives: Drug: Povidone-Iodine |
| B (Control) | No intervention | Esophageal resection will be performed without esophageal washout. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local carcinoma recurrence
Defined as development of a local recurrence after surgical treatment for esophageal cancer. The tumor is of identical histopathological type and occurs either on remained parts of the esophagus, at the site of anastomosis, on parts of an interposed organ (i.e. jejunum or colon) or in the original esophageal bed.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study start16 Feb 2016
- Primary completion24 Sep 2021
- Study completion24 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Reißfelder, MD, Principal investigator, Department of GI, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676791
- Sponsor's protocol ID
- VTG-07
- Acronym
- LOCARE
- Status last verified
- Jul 2022
- First submitted
- 4 Feb 2016
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Esophageal Washout on Local Carcinoma Recurrence After Curative Resection - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02676791
- Acronym / sponsor ID
- LOCARE / VTG-07
- Conditions
- Esophageal Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- 16 Feb 2016 (actual)
- Primary completion
- 24 Sep 2021 (actual)
- Study completion
- 24 Sep 2021 (actual)
- First posted
- 8 Feb 2016 (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 LOCARE-Trial is an investigator initiated, randomized-controlled trial with two parallel arms (n=60 each) and investigates the influence of esophageal washout on long-term outcomes in patients undergoing elective esophageal resection for carcinoma. The primary endpoint is defined as local carcinoma recurrence. Secondary endpoints will be locoregional and distant recurrence, disease-specific survival and esophageal cancer specific survival.
Detailed description
Treatment of squamous cell carcinoma and adenocarcinoma of the esophagus has changed rapidly over the last decades due to implementation of multimodal cancer therapies such as radiotherapy or combined radiochemotherapy. Surgery, however, still is the mainstay of curative treatment options for this cancer entity. Due to the significant improvement in surgical technique and perioperative management, the postoperative mortality rate has fallen to about 5% with an estimated 5-year survival of 35%. Nevertheless, patients after esophagectomy are at high risk for local recurrence especially within the first 2 years after treatment. Independent risk factors for the development of carcinoma recurrence are incomplete resection (R1), extracapsular lymph node involvement and postoperative complications. Exfoliated, malignant cells remaining in luminal organs like the esophagus or colorectum could present another important risk factor for local recurrence especially at the site of anastomosis. In the treatment of rectal cancer, data have shown, that intraoperative rectal washout significantly reduces the risk of local recurrence from about 10% to 5%. For this reason, rectal washout during anterior resection has become a standard in many surgical institutions. Besides agents like cetrimide, sodium hypochlorite, formalin or saline, povidone-iodine has also been used for rectal mucosal application in prospective studies. Questions arise, weather similar positive outcomes could be achieved in esophageal surgery. The investigators hypothesize that esophageal washout with a povidone-iodine solution (Betaisodona®, Mundipharma) reduces the risk of local carcinoma recurrence after radical resection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A (Povidone-Iodine) | Experimental | Drug: Povidone-IodineEsophageal washout will be performed via a nasogastric tube with approx. 50ml of a 11% povidone-iodine solution (Betaisodona®, Mundipharma) during esophageal resection. |
| B (Control) | No intervention | –Esophageal resection will be performed without esophageal washout. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients scheduled for elective esophageal resection or esophagectomy
- Age equal or greater than 18 years
- Written informed consent
- Squamous cell carcinoma of the esophagus (SCC)
- Adenocarcinoma of the gastroesophageal junction (AEG) Type I
Key exclusion criteria (6 listed)
- Local irresectability or metastatic disease
- Adenocarcinoma of the gastroesophageal junction Type II and III
- Histopathological R1-resection
- Surgery for recurrence
- Iodine allergy
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 |
|---|---|---|
| Povidone-IodineAlso: BetaisodonaA standard nasogastric tube will be inserted into all patients after induction of general anesthesia. After surgical dissection, the esophagus / stomach will be cut at the desired level leaving the tip of the nasogastric tube proximal to the esophageal carcinoma. Then, 50ml of a 11% povidone-iodine solution (Betaisodona®, Mundipharma) will be introduced into the esophagus via the nasogastric tube and evacuated with a suction device (washout). The nasogastric tube will then be removed for completion of esophageal resection and beginning of reconstruction. | Drug | A (Povidone-Iodine) |
Primary outcome
Local carcinoma recurrence
Time frame: 36 months
Defined as development of a local recurrence after surgical treatment for esophageal cancer. The tumor is of identical histopathological type and occurs either on remained parts of the esophagus, at the site of anastomosis, on parts of an interposed organ (i.e. jejunum or colon) or in the original esophageal bed.
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 14 Jul 2022.
- 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.
Christoph Reißfelder, MD principal investigator
Department of GI, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Povidone-Iodine in people with Esophageal Neoplasms, run by Technische Universität Dresden 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 5 inclusion and 6 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 14 Jul 2022. 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?
Local carcinoma recurrence (time frame: 36 months). 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 14 Jul 2022.