Esophageal CancerNCT06879483
Thoraco-laparoscopic Partial Esophagogastrectomy for Management of Esophageal Cancer
A study testing Thoraco-laparoscopic partial esophagogastrectomy in people with Esophageal Cancer, run by Sohag University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Thoraco-laparoscopic partial esophagogastrectomy
- 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
- 1 Sep 2025to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with resectable esophageal cancer (stages I-III).
- Suitable for thoraco-laparoscopic partial esophagogastrectomy.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Who cannot join
- Presence of distant metastasis at diagnosis.
- History of previous esophageal or gastric surgery.
- Contraindications to laparoscopy or thoracoscopy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
ahmed m salah eldin, assistant lecturer of general contact
Egypt1 site
Sohag Faculty of Medicine
Sohag
ahmed m salah eldin, assistant lecturer, +201001329315, ahmed_mohamed2@med.sohag.edu.eg
About this study
Official title: 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.
- Conditions
- Esophageal Cancer
- Being tested
- Thoraco-laparoscopic partial esophagogastrectomy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoraco-laparoscopic partial esophagogastrectomyProcedure or surgery
- 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
- 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.
- Reconstruction:
- An anastomosis (esophagogastric connection) is performed to restore continuity, typically using a circular stapler or hand-sewn technique.
| Study group | Role | What they receive |
|---|---|---|
| Thoraco-laparoscopic partial esophagogastrectomy | Experimental | Patients diagnosed with resectable esophageal cancer will undergo thoraco-laparoscopic partial esophagogastrectomy Receives: Procedure: Thoraco-laparoscopic partial esophagogastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate Postoperative complications
30-day morbidity and mortality (using Clavien-Dindo classification)
Measured: first month post operative
Dysphagia
yes or no
Measured: Collected at base line preoperative,one month, and 12 months post-surgery.
resection margin status
resection margin status (R0/R1/R2)
Measured: 2 weeks postoperative
lymph node yield.
number of lymph nodes in specimen
Measured: first month post operative
regurgitation
yes or no
Measured: Collected at one month, and 12 months post-surgery.
Secondary outcomes (3)
recurrence rate
Measured: first year post operative
body mass index
Measured: Collected at base line preoperative,one month, and 12 months post-surgery.
serum albumin
Measured: Collected at base line preoperative,one month, and 12 months post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Collaborators
- Mansoura University
- Responsible party
- Principal investigator, Ahmed Mahrous Salaheldin, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879483
- Sponsor's protocol ID
- Soh-Med-25-2-5MD
- Status last verified
- Feb 2025
- First submitted
- 6 Mar 2025
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early and Intermediate Term Outcomes of Thoraco-laparoscopic Partial Esophagogastrectomy for Management of Esophageal Cancer
- ClinicalTrials.gov ID
- NCT06879483
- Acronym / sponsor ID
- Soh-Med-25-2-5MD
- Conditions
- Esophageal Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Collaborators
- Mansoura University
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thoraco-laparoscopic partial esophagogastrectomy | Experimental | Procedure: Thoraco-laparoscopic partial esophagogastrectomyPatients diagnosed with resectable esophageal cancer will undergo thoraco-laparoscopic partial esophagogastrectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with resectable esophageal cancer (stages I-III).
- Suitable for thoraco-laparoscopic partial esophagogastrectomy.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Key exclusion criteria (3 listed)
- Presence of distant metastasis at diagnosis.
- History of previous esophageal or gastric surgery.
- Contraindications to laparoscopy or thoracoscopy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoraco-laparoscopic partial esophagogastrectomy1. 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. | Procedure or surgery | Thoraco-laparoscopic partial esophagogastrectomy |
Primary outcome
Immediate Postoperative complications
Time frame: first month post operative
30-day morbidity and mortality (using Clavien-Dindo classification)
Dysphagia
Time frame: Collected at base line preoperative,one month, and 12 months post-surgery.
yes or no
resection margin status
Time frame: 2 weeks postoperative
resection margin status (R0/R1/R2)
lymph node yield.
Time frame: first month post operative
number of lymph nodes in specimen
regurgitation
Time frame: Collected at one month, and 12 months post-surgery.
yes or no
3 secondary outcomes
recurrence rate
Time frame: first year post operative
body mass index
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ahmed m salah eldin, assistant lecturer of general contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoraco-laparoscopic partial esophagogastrectomy 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 3 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: opening soon, as of the sponsor's last update on 17 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ahmed m salah eldin, assistant lecturer of general (+201001329315, ahmed_mohamed2@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate Postoperative complications (time frame: first month post operative). The study lists 5 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 17 Mar 2025.