POsitioning for Esophageal Cancer Resection

Esophageal Cancer Clinical Trial

— POETRI  

Official title:

POsitioning for Esophageal Cancer Resection - a Randomized Controlled TRIal (POETRI)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02157363
• Other study ID #: TW-001
• Status: Terminated
• Phase: N/A
• First received: May 12, 2014
• Last updated: October 19, 2017
• Start date: June 16, 2014
• Est. completion date: February 28, 2017

Study information

• Verified date: October 2017
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 47
• Est. completion date: February 28, 2017
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Procedure:
• Repositioning

• Single positioning

Locations

Country	Name	City	State
Germany	Department of Surgery, University Hospital Dresden	Dresden

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	operating time	Operating time is defined from the start of patient positioning until final closing and dressing of all wounds.	The endpoint is assessed at the end of the operation (finishing of all wound dressings) on the day of operation.