Clinical trial NCT02676791: Influence of Esophageal Washout on Local Carcinoma Recurrence After Curative Resection
Official title: Influence of Esophageal Washout on Local Carcinoma Recurrence After Curative Resection - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Neoplasms
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2016-02-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Local carcinoma recurrence
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Department of GI, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden
Study officials:
affiliation: Department of GI, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden
name: Christoph Reißfelder, MD
role: PRINCIPAL_INVESTIGATOR
References: