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Esophageal CancerNCT05662644

Assessment of Minimally Invasive Surgery for Esophageal Cancer

A study testing Minimally Invasive Surgery for Esophageal Cancer in people with Esophageal Cancer, run by Sohag University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Esophageal Cancer
What is being tested?
Minimally Invasive Surgery for Esophageal Cancer
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteEgypt
Study dates
Dec 2022to Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Ahmed A Kenawy, MD candidate contact

1021025880 ext. +20

ahmed.qenawi@med.sohag.edu.eg

Egypt1 site
  • Sohag university

    Sohag, 82511

    Ahmed A Kenawy, MD candidate, 1021025880 ext. +20, ahmed.qenawi@med.sohag.edu.eg

Other trials in Egypt

About this study

Official title: Minimally Invasive Surgery for Esophageal Cancer: Feasibility and Outcome

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
  1. Peri-operative outcome including
  • Operative time
  • Conversion to open
  • Blood loss
  • Hospital stays
  1. Evaluation of recurrence, disease-free survival and overall survival rates: according to The Kaplan-Meier estimator
  2. Morbidity and mortality.
Read the 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
  1. Peri-operative outcome including
  • Operative time
  • Conversion to open
  • Blood loss
  • Hospital stays
  1. Evaluation of recurrence, disease-free survival and overall survival rates: according to The Kaplan-Meier estimator
  2. 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.
  1. Exclusion criteria:
  • Metastatic patients.
  • Locally advanced cases.
  • Patients with comorbidities who are unfit for major surgical procedures.
  • Patients with contraindications for laparoscopy or thoracoscopy.
  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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).
  7. Source of funding:

Self-funding.

Being tested
Minimally Invasive Surgery for Esophageal Cancer
Keywords
Minimally invasive, Esophageal Cancer, feasibility, outcome
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Minimally Invasive Surgery for Esophageal CancerProcedure or surgery

    Assessment of minimally Invasive Surgery for Esophageal Cancer

Study groups in NCT05662644
Study groupRoleWhat they receive
Feasibility of Esophagectomy Esophageal CancerActive comparatorMinimally Invasive Surgery for Esophageal Cancer: feasibility
Receives: Procedure: Minimally Invasive Surgery for Esophageal Cancer
Outcome of Esophagectomy Esophageal CancerActive comparatorMinimally Invasive Surgery for Esophageal Cancer: outcome
Receives: Procedure: Minimally Invasive Surgery for Esophageal Cancer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration of Operatiion

    minutes

    Measured: 1 day postoperative

  2. Duration of hospital stay

    Days

    Measured: 2 weeks postoperative

  3. Type of Surgical technique

    Thoracoscopic, laparoscopic or combined

    Measured: 1 day postoperative

  4. Status of surgical margins

    Free or not

    Measured: 2 weeks postoperative

  5. Number of lymph nodes

    numbers

    Measured: 2 weeks postoperative

  6. occurence of Conversion to open

    yes or no

    Measured: 1 day postoperative

  7. Amount of Blood loss

    Milliliters

    Measured: 1 day postoperative

  8. Incidence of recurrence

    yes or no

    Measured: 6 months postoperative

  9. Occurrence of intraoperative vascular injury

    yes or no

    Measured: 1 day postoperative

  10. Occurence of anastomotic leakage

    yes or no

    Measured: 4 weeks postoperative

  11. Administration of neoadjuvant therapy

    yes or no

    Measured: 2 weeks preoperative

  12. Level of preoperative Haemoglobin

    g/dl

    Measured: 1 week preoperative

  13. Level of postoperative Haemoglobin

    g/dl

    Measured: 1 week postoperative

  14. Level of CEA preoperative

    ng/ml

    Measured: 2 weeks preoperative

  15. Level of CEApostoperative

    ng/ml

    Measured: 4 weeks postoperative

  16. Occurence lung injury

    yes or no

    Measured: 1 day postoperative

  17. site of pathology

    upper / middle or lower esophageal

    Measured: 1 day preoperative

  18. type of anastomosis

    stapler or hand sewing

    Measured: 1 day postoperative

  19. Nature of gross picture of specimen

    mass / ulcer

    Measured: 2 weeks postoperative

Secondary outcomes (3)
  1. Occurence of mortality

    yes or no

    Measured: 6 weeks postoperative

  2. Occurence of anastomotic stenosis

    yes or no

    Measured: 6 weeks postoperative

  3. Occurence of ostoperative reflux

    yes or no

    Measured: 6 weeks postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2022
  2. Study startDec 2022 (estimated)
  3. Primary completionDec 2023 (estimated)
  4. Study completionApr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
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)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05662644
Sponsor's protocol ID
Soh-Med-22-11-10
Status last verified
Dec 2022
First submitted
5 Dec 2022
Last updated
22 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Not yet decided

Questions about this trial

What is this clinical trial studying?

A study testing Minimally Invasive Surgery for Esophageal Cancer in people with Esophageal Cancer, run by Sohag University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ahmed A Kenawy, MD candidate (1021025880 ext. +20, ahmed.qenawi@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of Operatiion (time frame: 1 day postoperative). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.

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