POsitioning for Esophageal Cancer Resection
Conditions
Esophageal Cancer
Conditions: official terms
Esophageal Neoplasms
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Repositioning Type: Procedure
Name: Single positioning Type: Procedure
Overall Status
Recruiting
Summary
Open thoracoabdominal esophagectomy (TAE) is the standard curative treatment modality for resectable esophageal cancer. TAE can be achieved by positioning the patient in the supine position for the abdominal part and in a left-lateral decubitus (LLD) position for the thoracic part, or by performing both parts in a left-screwed supine position (LSS). Aim of the present study is to compare peri- and postoperative outcome variables after TAE for esophageal cancer in the two positions.

POETRI is designed as a single-center, randomized controlled trial with two parallel arms including patients with resectable esophageal cancer and type I cancers of the esophagogastric junction (AEG I). Exclusion criteria are inability to tolerate surgery or both types of positioning, inability to perform an intrathoracic anastomosis, non-malignant pathologies. The primary endpoint is operating time. Secondary endpoints are morbidity, lymph node yield, pulmonary function, pain control and wound healing assessed during a follow-up of 3 months.

POETRI is a single-center, randomized controlled trial to evaluate different positioning and thoracic access during radical open thoracoabdominal esophagectomy for patients with resectable esophageal cancer.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Newly diagnosed, non-metastatic esophagus cancer (squamous or adenocarcinoma) or AEG I tumors requiring curative thoracoabdominal esophagectomy with intrathoracic anastomosis of a gastric tube immediately after diagnosis or after neoadjuvant treatment

- Patients are considered fit for surgery by a local interdisciplinary team of surgeons, medical oncologists and anesthesiologists (ECOG performance status of 0,1, or 2).

- Age ≥ 18 years

- Written informed consent

Exclusion Criteria:

- Preoperative established indication for colon interposition or cervical anastomosis

- Preoperative diagnosed tracheo-esophageal fistula

- History of right thoracotomy or prior lung surgery

- Physical inability of the described intraoperative patient positioning

- Non-malignant esophageal pathology or other malignancies except squamous or adenocarcinoma

- Planned laparoscopic or thoracoscopic surgical approach

- Patients not eligible for TAE (ASA ≥ 4)
Location
Department of Surgery, University Hospital Dresden
Dresden, Germany
Status: Recruiting
Contact: Thilo Welsch, MD - thilo.welsch@uniklinikum-dresden.de
Start Date
June 2014
Completion Date
September 2016
Sponsors
Technische Universität Dresden
Source
Technische Universität Dresden
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page