Assessment of Minimally Invasive Surgery for Esophageal Cancer

NCT05662644 | Unknown

• 1 other identifier: Soh-Med-22-11-10
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

• 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.

Conditions

Esophageal Cancer

Keywords

Minimally invasive; Esophageal Cancer; feasibility; outcome

Outcome Measures

Primary Outcomes (19)

• Duration of Operatiion

  minutes

  1 day postoperative

• Duration of hospital stay

  Days

  2 weeks postoperative

• Type of Surgical technique

  Thoracoscopic, laparoscopic or combined

  1 day postoperative

• Status of surgical margins

  Free or not

  2 weeks postoperative

• Number of lymph nodes

  numbers

  2 weeks postoperative

• occurence of Conversion to open

  yes or no

  1 day postoperative

• Amount of Blood loss

  Milliliters

  1 day postoperative

• Incidence of recurrence

  yes or no

  6 months postoperative

• Occurrence of intraoperative vascular injury

  yes or no

  1 day postoperative

• Occurence of anastomotic leakage

  yes or no

  4 weeks postoperative

• Administration of neoadjuvant therapy

  yes or no

  2 weeks preoperative

• Level of preoperative Haemoglobin

  g/dl

  1 week preoperative

• Level of postoperative Haemoglobin

  g/dl

  1 week postoperative

• Level of CEA preoperative

  ng/ml

  2 weeks preoperative

• Level of CEApostoperative

  ng/ml

  4 weeks postoperative

• Occurence lung injury

  yes or no

  1 day postoperative

• site of pathology

  upper / middle or lower esophageal

  1 day preoperative

• type of anastomosis

  stapler or hand sewing

  1 day postoperative

• Nature of gross picture of specimen

  mass / ulcer

  2 weeks postoperative

Secondary Outcomes (3)

• Occurence of mortality

  6 weeks postoperative

• Occurence of anastomotic stenosis

  6 weeks postoperative

• Occurence of ostoperative reflux

  6 weeks postoperative

Study Arms (2)

Feasibility of Esophagectomy Esophageal Cancer

ACTIVE COMPARATOR

Minimally Invasive Surgery for Esophageal Cancer: feasibility

Procedure: Minimally Invasive Surgery for Esophageal Cancer

Outcome of Esophagectomy Esophageal Cancer

ACTIVE COMPARATOR

Minimally Invasive Surgery for Esophageal Cancer: outcome

Procedure: Minimally Invasive Surgery for Esophageal Cancer

Interventions

Minimally Invasive Surgery for Esophageal Cancer PROCEDURE

Assessment of minimally Invasive Surgery for Esophageal Cancer

Feasibility of Esophagectomy Esophageal Cancer; Outcome of Esophagectomy Esophageal Cancer

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university

Sohag, 82511, Egypt

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Minimally Invasive Surgical Procedures

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)

Surgical Procedures, Operative

Study Officials

• Ahmed A Kenawy, MD

  Sohag University

  PRINCIPAL INVESTIGATOR

• Alaa-Eldin H Mohamed, professor

  Sohag University

  STUDY CHAIR

• Alaa A Redwan, professor

  Sohag University

  STUDY DIRECTOR

• Haitham F Othman, MD

  National Cancer Institute (NCI)

  STUDY DIRECTOR

Central Study Contacts

Ahmed A Kenawy, MD candidate

CONTACT

1021025880; ahmed.qenawi@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: teaching assistant

Model Details: All patients with esophageal cancer who are considered candidates for esophagectomy present to NCI in the period starting fromDecember 2022

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 22, 2022
• Study Start: December 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: April 1, 2024
• Last Updated: December 22, 2022

Record last verified: 2022-12

Locations

EG (1)