Thoraco-laparoscopic Partial Esophagogastrectomy for Management of Esophageal Cancer

March 13, 2025 updated by: Ahmed Mahrous Salaheldin, Sohag University

Early and Intermediate Term Outcomes of Thoraco-laparoscopic Partial Esophagogastrectomy for Management of Esophageal Cancer

Thoraco-laparoscopic partial esophagogastrectomy has emerged as a promising minimally invasive alternative, combining thoracoscopy and laparoscopy to reduce the trauma associated with open surgery.Early and intermediate-term outcomes provide critical information on both the oncological efficacy and functional benefits of the procedure. By examining recurrence rates within the first 12-24 months, this study will provide valuable insights into the oncological robustness of this approach compared to more invasive approaches.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients diagnosed with resectable esophageal cancer (stages I-III).
  • Suitable for thoraco-laparoscopic partial esophagogastrectomy.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

Exclusion Criteria:

  • Presence of distant metastasis at diagnosis.
  • History of previous esophageal or gastric surgery.
  • Contraindications to laparoscopy or thoracoscopy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Thoraco-laparoscopic partial esophagogastrectomy
Patients diagnosed with resectable esophageal cancer will undergo thoraco-laparoscopic partial esophagogastrectomy
Procedure: Thoraco-laparoscopic partial esophagogastrectomy

  1. Laparoscopic Phase:

    • The stomach is mobilized, and a part of it is resected to include the lower esophageal segment.
    • Left gastric nodes, the splenic and common hepatic nodes are dissected.
    • A gastric tube is created using endoscopic staplers for esophageal reconstruction and fixed to the proximal gastrectomy specimen using sutures

  2. Thoracoscopic Phase:

    • The patient is positioned in prone position
    • Three small incisions are made in the thorax
    • Further esophageal mobilization through a right thoracoscopy is performed in left lateral decubitus. Periesophageal nodes are retrieved en bloc. Left and right paratracheal and subcarinal lymph nodes are resected separately. The esophagus is transected at the tumor's proximal margin.

  3. Reconstruction:

    • An anastomosis (esophagogastric connection) is performed to restore continuity, typically using a circular stapler or hand-sewn technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immediate Postoperative complications
Time Frame: first month post operative
30-day morbidity and mortality (using Clavien-Dindo classification)
first month post operative
Dysphagia
Time Frame: Collected at base line preoperative,one month, and 12 months post-surgery.
yes or no
Collected at base line preoperative,one month, and 12 months post-surgery.
resection margin status
Time Frame: 2 weeks postoperative
resection margin status (R0/R1/R2)
2 weeks postoperative
lymph node yield.
Time Frame: first month post operative
number of lymph nodes in specimen
first month post operative
regurgitation
Time Frame: Collected at one month, and 12 months post-surgery.
yes or no
Collected at one month, and 12 months post-surgery.

Secondary Outcome Measures

Outcome Measure
Time Frame
recurrence rate
Time Frame: first year post operative
first year post operative
body mass index
Time Frame: Collected at base line preoperative,one month, and 12 months post-surgery.
Collected at base line preoperative,one month, and 12 months post-surgery.
serum albumin
Time Frame: Collected at base line preoperative,one month, and 12 months post-surgery.
Collected at base line preoperative,one month, and 12 months post-surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Collaborators

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

March 6, 2025

First Submitted That Met QC Criteria

March 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 13, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-25-2-5MD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Esophageal Cancer

Clinical Trials on Thoraco-laparoscopic partial esophagogastrectomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe