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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Germany
      • Dresden, Germany
        • Department of GI, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Povidone-Iodine
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:
  • Betaisodona
No Intervention: B (Control)
Esophageal resection will be performed without esophageal washout.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Technische Universität Dresden

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 16, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 24, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 24, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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