Clinical trial NCT02157363: POsitioning for Esophageal Cancer Resection
Official title: POsitioning for Esophageal Cancer Resection - a Randomized Controlled TRIal (POETRI)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Esophageal Cancer
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2014-06-06
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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)

Primary outcomes:
measure: operating time
timeFrame: The endpoint is assessed at the end of the operation (finishing of all wound dressings) on the day of operation.
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Department of Surgery, University Hospital Dresden
Study officials:
affiliation: Department of Surgery, University Hospital Dresden
name: Thilo Welsch, MD
role: PRINCIPAL_INVESTIGATOR
References: