POsitioning for Esophageal Cancer Resection

NCT02157363 | Terminated DMC

• 1 other identifier: TW-001
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Repositioning Group

ACTIVE COMPARATOR

The patient is placed on a vacuum mattress in supine position for the abdominal part using a midline laparotomy. After completion of the abdominal part, the abdomen is closed and dressed in standard fashion and the patient is repositioned under full anesthesia is a left-lateral decubitus (LLD) position. After the thorax is sterile prepped and draped, a right dorso-lateral thoracotomy in the 4th to 6th intercostal space under preservation of body of the serratus muscle is performed.

Procedure: Repositioning

Single positioning

EXPERIMENTAL

The patient is placed on a vacuum mattress and in a left-screwed supine position for the entire operative procedure. The pelvis and the lower extremities are placed at 0° rotation, whereas the torso is rotated leftwards to an angle of 45° (Fig. 1). The patient is prepped and draped from the shoulders to the inguinal region. A midline laparotomy is done for the abdominal part and the abdomen closed afterwards. For the thoracic part, the operating table is tilted about 30° to the left, and a right anterolateral thoracotomy is performed in the 4th to 6th intercostal space.

Procedure: Single positioning

Interventions

Repositioning PROCEDURE

Repositioning Group

Single positioning PROCEDURE

Single positioning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Technische Universität Dresden: lead

Study Sites (1)

Department of Surgery, University Hospital Dresden

Dresden, 01307, Germany

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Patient Positioning

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Thilo Welsch, MD

  Department of Surgery, University Hospital Dresden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2014
• First Posted: June 6, 2014
• Study Start: June 16, 2014
• Primary Completion: February 28, 2017
• Study Completion: February 28, 2017
• Last Updated: October 20, 2017

Record last verified: 2017-10

Locations

DE (1)