Influence of Esophageal Washout on Local Carcinoma Recurrence After Curative Resection

NCT ID: NCT02676791

Last Updated: 2022-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-16
• Study Completion Date: 2021-09-24

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.

Conditions

Esophageal Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Povidone-Iodine

Intervention Type: 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.

B (Control)

Esophageal resection will be performed without esophageal washout.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Betaisodona

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technische Universität Dresden

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christoph Reißfelder, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Dresden, , Germany

Countries

Germany

Other Identifiers

VTG-07

Identifier Type: -

Identifier Source: org_study_id