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Influence of Esophageal Washout on Local Carcinoma Recurrence After Curative Resection

NCT02676791 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-07-14

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Technische Universität Dresden

    lead OTHER

Principal Investigators

  • Christoph Reißfelder, MD · Department of GI, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-16
Primary Completion
2021-09-24
Completion
2021-09-24

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02676791 on ClinicalTrials.gov