Thoraco-laparoscopic Partial Esophagogastrectomy for Management of Esophageal Cancer

NCT06879483 | Not Yet Recruiting

• 1 other identifier: Soh-Med-25-2-5MD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (5)

• Immediate Postoperative complications

  30-day morbidity and mortality (using Clavien-Dindo classification)

  first month post operative

• Dysphagia

  yes or no

  Collected at base line preoperative,one month, and 12 months post-surgery.

• resection margin status

  resection margin status (R0/R1/R2)

  2 weeks postoperative

• lymph node yield.

  number of lymph nodes in specimen

  first month post operative

• regurgitation

  yes or no

  Collected at one month, and 12 months post-surgery.

Secondary Outcomes (3)

• recurrence rate

  first year post operative

• body mass index

  Collected at base line preoperative,one month, and 12 months post-surgery.

• serum albumin

  Collected at base line preoperative,one month, and 12 months post-surgery.

Study Arms (1)

Thoraco-laparoscopic partial esophagogastrectomy

EXPERIMENTAL

Patients diagnosed with resectable esophageal cancer will undergo thoraco-laparoscopic partial esophagogastrectomy

Procedure: Thoraco-laparoscopic partial esophagogastrectomy

Interventions

Thoraco-laparoscopic partial esophagogastrectomy PROCEDURE

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.

Thoraco-laparoscopic partial esophagogastrectomy

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sohag University: lead
• Mansoura University: collaborator

Study Sites (1)

Sohag Faculty of Medicine

Sohag, Egypt

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

ahmed m salah eldin, assistant lecturer of general

CONTACT

+201001329315; ahmed_mohamed2@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assisstant lecturer of general surgery

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 17, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 17, 2025

Record last verified: 2025-02

Locations

EG (1)