Assessment of Minimally Invasive Surgery for Esophageal Cancer
Primary Purpose
Esophageal Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Minimally Invasive Surgery for Esophageal Cancer
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring Minimally invasive, Esophageal Cancer, feasibility, outcome
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.
Sites / Locations
- Sohag university
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Feasibility of Esophagectomy Esophageal Cancer
Outcome of Esophagectomy Esophageal Cancer
Arm Description
Minimally Invasive Surgery for Esophageal Cancer: feasibility
Minimally Invasive Surgery for Esophageal Cancer: outcome
Outcomes
Primary Outcome Measures
Duration of Operatiion
minutes
Duration of hospital stay
Days
Type of Surgical technique
Thoracoscopic, laparoscopic or combined
Status of surgical margins
Free or not
Number of lymph nodes
numbers
occurence of Conversion to open
yes or no
Amount of Blood loss
Milliliters
Incidence of recurrence
yes or no
Occurrence of intraoperative vascular injury
yes or no
Occurence of anastomotic leakage
yes or no
Administration of neoadjuvant therapy
yes or no
Level of preoperative Haemoglobin
g/dl
Level of postoperative Haemoglobin
g/dl
Level of CEA preoperative
ng/ml
Level of CEApostoperative
ng/ml
Occurence lung injury
yes or no
site of pathology
upper / middle or lower esophageal
type of anastomosis
stapler or hand sewing
Nature of gross picture of specimen
mass / ulcer
Secondary Outcome Measures
Occurence of mortality
yes or no
Occurence of anastomotic stenosis
yes or no
Occurence of ostoperative reflux
yes or no
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05662644
Brief Title
Assessment of Minimally Invasive Surgery for Esophageal Cancer
Official Title
Minimally Invasive Surgery for Esophageal Cancer: Feasibility and Outcome
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2022 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluate the feasibility and outcome of minimally invasive management of esophageal cancer regarding
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.
Histopathology
Assessment of surgical margins
Assessment of the number of lymph nodes
Peri-operative outcome including
Operative time
Conversion to open
Blood loss
Hospital stays
Evaluation of recurrence, disease-free survival and overall survival rates: according to The Kaplan-Meier estimator
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
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.
Histopathology
Assessment of surgical margins
Assessment of the number of lymph nodes
Peri-operative outcome including
Operative time
Conversion to open
Blood loss
Hospital stays
Evaluation of recurrence, disease-free survival and overall survival rates: according to The Kaplan-Meier estimator
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:
Population of study & disease Condition patients with esophageal cancer.
Background and Demographic characteristics Any patient with esophageal cancer is considered a candidate for a minimally invasive esophagectomy procedure.
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.
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.
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.
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.
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.
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.
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).
Source of funding:
Self-funding.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
Minimally invasive, Esophageal Cancer, feasibility, outcome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All patients with esophageal cancer who are considered candidates for esophagectomy present to NCI in the period starting fromDecember 2022
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Feasibility of Esophagectomy Esophageal Cancer
Arm Type
Active Comparator
Arm Description
Minimally Invasive Surgery for Esophageal Cancer: feasibility
Arm Title
Outcome of Esophagectomy Esophageal Cancer
Arm Type
Active Comparator
Arm Description
Minimally Invasive Surgery for Esophageal Cancer: outcome
Intervention Type
Procedure
Intervention Name(s)
Minimally Invasive Surgery for Esophageal Cancer
Intervention Description
Assessment of minimally Invasive Surgery for Esophageal Cancer
Primary Outcome Measure Information:
Title
Duration of Operatiion
Description
minutes
Time Frame
1 day postoperative
Title
Duration of hospital stay
Description
Days
Time Frame
2 weeks postoperative
Title
Type of Surgical technique
Description
Thoracoscopic, laparoscopic or combined
Time Frame
1 day postoperative
Title
Status of surgical margins
Description
Free or not
Time Frame
2 weeks postoperative
Title
Number of lymph nodes
Description
numbers
Time Frame
2 weeks postoperative
Title
occurence of Conversion to open
Description
yes or no
Time Frame
1 day postoperative
Title
Amount of Blood loss
Description
Milliliters
Time Frame
1 day postoperative
Title
Incidence of recurrence
Description
yes or no
Time Frame
6 months postoperative
Title
Occurrence of intraoperative vascular injury
Description
yes or no
Time Frame
1 day postoperative
Title
Occurence of anastomotic leakage
Description
yes or no
Time Frame
4 weeks postoperative
Title
Administration of neoadjuvant therapy
Description
yes or no
Time Frame
2 weeks preoperative
Title
Level of preoperative Haemoglobin
Description
g/dl
Time Frame
1 week preoperative
Title
Level of postoperative Haemoglobin
Description
g/dl
Time Frame
1 week postoperative
Title
Level of CEA preoperative
Description
ng/ml
Time Frame
2 weeks preoperative
Title
Level of CEApostoperative
Description
ng/ml
Time Frame
4 weeks postoperative
Title
Occurence lung injury
Description
yes or no
Time Frame
1 day postoperative
Title
site of pathology
Description
upper / middle or lower esophageal
Time Frame
1 day preoperative
Title
type of anastomosis
Description
stapler or hand sewing
Time Frame
1 day postoperative
Title
Nature of gross picture of specimen
Description
mass / ulcer
Time Frame
2 weeks postoperative
Secondary Outcome Measure Information:
Title
Occurence of mortality
Description
yes or no
Time Frame
6 weeks postoperative
Title
Occurence of anastomotic stenosis
Description
yes or no
Time Frame
6 weeks postoperative
Title
Occurence of ostoperative reflux
Description
yes or no
Time Frame
6 weeks postoperative
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed A Kenawy, MD candidate
Phone
1021025880
Ext
+20
Email
ahmed.qenawi@med.sohag.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed A Kenawy, MD
Organizational Affiliation
Sohag University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alaa-Eldin H Mohamed, professor
Organizational Affiliation
Sohag University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alaa A Redwan, professor
Organizational Affiliation
Sohag University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Haitham F Othman, MD
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Study Director
Facility Information:
Facility Name
Sohag university
City
Sohag
ZIP/Postal Code
82511
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed A Kenawy, MD candidate
Phone
1021025880
Ext
+20
Email
ahmed.qenawi@med.sohag.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Not yet decided
Learn more about this trial
Assessment of Minimally Invasive Surgery for Esophageal Cancer
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