- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02676791
Influence of Esophageal Washout on Local Carcinoma Recurrence After Curative Resection (LOCARE)
July 13, 2022 updated by: Technische Universität Dresden
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Dresden, Germany
- Department of GI, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Local irresectability or metastatic disease
- Adenocarcinoma of the gastroesophageal junction Type II and III
- Histopathological R1-resection
- Surgery for recurrence
- Iodine allergy
- Hyperthyreosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: A (Povidone-Iodine)
Esophageal washout will be performed via a nasogastric tube with approx.
50ml of a 11% povidone-iodine solution (Betaisodona®, Mundipharma) during esophageal resection.
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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.
Other Names:
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No Intervention: B (Control)
Esophageal resection will be performed without esophageal washout.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Local carcinoma recurrence
Time Frame: 36 months
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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.
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36 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christoph Reißfelder, MD, Department of GI, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 16, 2016
Primary Completion (Actual)
September 24, 2021
Study Completion (Actual)
September 24, 2021
Study Registration Dates
First Submitted
February 4, 2016
First Submitted That Met QC Criteria
February 5, 2016
First Posted (Estimate)
February 8, 2016
Study Record Updates
Last Update Posted (Actual)
July 14, 2022
Last Update Submitted That Met QC Criteria
July 13, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms
- Neoplasms by Site
- Disease Attributes
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Recurrence
- Esophageal Neoplasms
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Plasma Substitutes
- Blood Substitutes
- Povidone-Iodine
- Povidone
Other Study ID Numbers
- VTG-07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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