Influence of Esophageal Washout on Local Carcinoma Recurrence After Curative Resection

NCT02676791 | Completed DMC

• 1 other identifier: VTG-07
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. Secondary endpoints will be locoregional and distant recurrence, disease-specific survival and esophageal cancer specific survival.

Conditions

Esophageal Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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.

  36 months

Study Arms (2)

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.

Drug: Povidone-Iodine

B (Control)

NO INTERVENTION

Esophageal resection will be performed without esophageal washout.

Interventions

Povidone-Iodine DRUG

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.

Also known as: Betaisodona

A (Povidone-Iodine)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Local irresectability or metastatic disease
• Adenocarcinoma of the gastroesophageal junction Type II and III
• Histopathological R1-resection
• Surgery for recurrence
• Iodine allergy
• Hyperthyreosis

Sponsors & Collaborators

• Technische Universität Dresden: lead

Study Sites (1)

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

Dresden, Germany

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Povidone-Iodine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Christoph Reißfelder, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: February 8, 2016
• Study Start: February 16, 2016
• Primary Completion: September 24, 2021
• Study Completion: September 24, 2021
• Last Updated: July 14, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)