Assessment of Minimally Invasive Surgery for Esophageal Cancer

NCT ID: NCT05662644

Last Updated: 2022-12-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-31
• Study Completion Date: 2024-04-30

Brief Summary

Evaluate the feasibility and outcome of minimally invasive management of esophageal cancer regarding

1. Surgical technique:

A totally minimally invasive technique (combined thoracoscopic and laparoscopic approaches) for esophagectomy will be used in this study. Also, a hybrid technique (thoracoscopic approach with laparotomy or laparoscopic approach with thoracotomy) will be included.

2. Histopathology

• Assessment of surgical margins
• Assessment of the number of lymph nodes

3. Peri-operative outcome including

• Operative time
• Conversion to open
• Blood loss
• Hospital stays

4. Evaluation of recurrence, disease-free survival and overall survival rates: according to The Kaplan-Meier estimator

5. Morbidity and mortality.

Detailed Description

Introduction

Esophageal cancer is the seventh most common cause of cancer-related death worldwide. The overall five-year survival is below 20%.

It is characterized by its high mortality rate, poor prognosis at time of diagnosis and variability based on geographic location. Now , the prevalence of esophageal cancer is in transition .

The Arabic world has very low incidences of Esophageal cancer in general. In Egypt, it represents 1.7% of all cancers.

Esophagectomy followed by reconstruction surgery has been the most reliable modality for treatment in patients without evidence of disease spread.

Different surgical approaches, such as the Sweet esophagectomy, Ivor Lewis esophagectomy, McKeown esophagectomy, and transhiatal esophagectomy, have been used clinically based on specific locations in the esophageal cancer.

For cancer of the middle or lower segment of the thoracic esophagus, the Ivor Lewis esophagectomy and the Sweet esophagectomy through the left thoracic approach are the mainstream standard surgical approaches.

Conventional surgical treatment involves open esophagectomy (OE) using transthoracic or transhiatal approaches which are associated with high mortality and morbidity especially respiratory complications (RCs) that are common with open esophagectomy and can increase the risk of death by up to 20%.

Traditionally, an esophagectomy was performed through a right thoracotomy and laparotomy. However, these patients are at a high risk for developing postoperative pulmonary complications. In order to decrease postoperative morbidity, minimally invasive surgical techniques were introduced in the treatment of esophageal cancer.

The first thoracoscopic esophageal mobilizations for esophagectomy were performed in the early 1990s by A. Cuschieri.

Then, DePaula and colleagues and Swanström and Hansen separately published the first totally minimally invasive transhiatal esophagectomies in 1995 and 1997, respectively. Subsequently, many centers began to adapt their preferred technique to minimally invasive approaches and gained significant experience in laparoscopic and thoracoscopic approaches to esophagectomy.

Luketich et al. first identified the combined thoracoscopic esophageal mobilization followed by the laparoscopic fashioning of the gastric conduit and the development of an esophagogastric anastomosis in the cervical region.

In recent decades, minimally invasive esophagectomy (MIE) has become an alternative to open esophagectomy. minimally invasive esophagectomy (MIE) involves several techniques including total MIE (tMIE), hybrid minimally invasive esophagectomy (hMIE), and robotic surgery .

The procedure consists presently of three main techniques: combined thoracoscopic and laparoscopic approach (Ivor Lewis); thoracoscopic, laparoscopic, and cervical approach (three-hole); or laparoscopic and cervical approach only (transhiatal).

Luketich et al. subsequently published their approach to minimally invasive Ivor Lewis esophagectomy and intrathoracic anastomosis and concluded that this type of treatment is feasible.

MI McKeown esophagectomy procedure consists of thoracoscopic esophagectomy, laparoscopic gastric mobilization, and cervical anastomosis between the esophageal stump and gastric stump. With the improvement of techniques and equipment, McKeown MIE has received increased attention.

Objectives:

Evaluate the feasibility and outcome of minimally invasive management of esophageal cancer regarding

1. Surgical technique:

A totally minimally invasive technique (combined thoracoscopic and laparoscopic approaches) for esophagectomy will be used in this study. Also, a hybrid technique (thoracoscopic approach with laparotomy or laparoscopic approach with thoracotomy) will be included.

2. Histopathology

• Assessment of surgical margins
• Assessment of the number of lymph nodes

3. Peri-operative outcome including

• Operative time
• Conversion to open
• Blood loss
• Hospital stays

4. Evaluation of recurrence, disease-free survival and overall survival rates: according to The Kaplan-Meier estimator

5. Morbidity and mortality.

Aim of the work This study aims to evaluate the feasibility and outcome of minimally invasive management of esophageal cancer.

Study Design:

This study is going to be a prospective study where patients presenting with esophageal cancer who are considered candidates for surgery will undergo minimally invasive surgery. Each patient will be assessed in the pre, intra, and short postoperative period.

Methodology:

1. Population of study & disease Condition patients with esophageal cancer.

2. Background and Demographic characteristics Any patient with esophageal cancer is considered a candidate for a minimally invasive esophagectomy procedure.

3. Inclusion criteria:

• Any age.
• Any sex.
• Diagnostic operable esophageal cancer.

4. Exclusion criteria:

• Metastatic patients.
• Locally advanced cases.
• Patients with comorbidities who are unfit for major surgical procedures.
• Patients with contraindications for laparoscopy or thoracoscopy.

5. Interventions:

Patients with esophageal cancer who are considered candidates for surgery will be subjected to minimally invasive procedures through a combined laparoscopic and thoracoscopic approach with D2 dissection and mediastinal dissection.

6. Possible Risk:

The main risks are the same as Open esophagectomy Procedures as surgical site complications, pulmonary complications, bleeding, Leakage, mediastinitis, fluid collection, and stenosis.

Also, there is a risk of conversion from minimally invasive to open technique.

7. Primary outcome parameters:

The primary outcome will be the assessment of operative time, hospital stay, intraoperative and early postoperative complications, and the assessment of pathology regarding surgical margins and the retrieved lymph nodes.

8. Secondary outcome parameters:

The secondary outcome will be the incidence of late complications such as anastomotic stenosis and reflux symptoms and also the incidence of locoregional recurrence.

9. Sample size (number of participants included) All patients with esophageal cancer who are considered candidates for esophagectomy present to NCI in the period of 2 years starting November 2022 till October 2024.

10. Statistical analysis:

Data will be collected in preformed data collection before being entered in the spreadsheet. Statistical analysis will be performed using the statistical package for social science (SPSS). Continuous variables will be expressed as mean and standard deviation (normally distributed data) or median and range (not normally distributed data) while categorical data expressed as numbers and percentages.

Chi-square test will be used to compare the nominal data while continuous data will be compared by the student t-test (normally distributed data) and Mann-Whitney test (not normally distributed data).

11. Source of funding:

Self-funding.

Conditions

Esophageal Cancer

Keywords

Minimally invasive; Esophageal Cancer; feasibility; outcome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Feasibility of Esophagectomy Esophageal Cancer

Minimally Invasive Surgery for Esophageal Cancer: feasibility

Group Type: ACTIVE_COMPARATOR

Minimally Invasive Surgery for Esophageal Cancer

Intervention Type: PROCEDURE

Assessment of minimally Invasive Surgery for Esophageal Cancer

Outcome of Esophagectomy Esophageal Cancer

Minimally Invasive Surgery for Esophageal Cancer: outcome

Group Type: ACTIVE_COMPARATOR

Minimally Invasive Surgery for Esophageal Cancer

Intervention Type: PROCEDURE

Assessment of minimally Invasive Surgery for Esophageal Cancer

Interventions

Minimally Invasive Surgery for Esophageal Cancer

Assessment of minimally Invasive Surgery for Esophageal Cancer

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Any age.
• Any sex.
• Diagnostic operable esophageal cancer.

Exclusion Criteria

• Metastatic patients.
• Locally advanced cases.
• Patients with comorbidities who are unfit for major surgical procedures.
• Patients with contraindications for laparoscopy or thoracoscopy.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Abd Elraheem Mohamed Kenawy

teaching assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed A Kenawy, MD

Role: PRINCIPAL_INVESTIGATOR

Sohag University

Alaa-Eldin H Mohamed, professor

Role: STUDY_CHAIR

Sohag University

Alaa A Redwan, professor

Role: STUDY_DIRECTOR

Sohag University

Haitham F Othman, MD

Role: STUDY_DIRECTOR

National Cancer Institute (NCI)

Locations

Sohag university

Sohag, , Egypt

Countries

Egypt

Central Contacts

Ahmed A Kenawy, MD candidate

Role: CONTACT

Phone: 1021025880

Email: ahmed.qenawi@med.sohag.edu.eg

Facility Contacts

Ahmed A Kenawy, MD candidate

Role: primary

Other Identifiers

Soh-Med-22-11-10

Identifier Type: -

Identifier Source: org_study_id