Esophagogastric Junction CarcinomaNCT06162767
Cancer of Esophagogastric Junction: Optimized Sweet Versus Ivor-Lewis
A study testing Esophagectomy by Ivor-Lewis Procedure and Esophagectomy by Optimized Sweet Procedure in people with Esophagogastric Junction Carcinoma, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
This study is being done to see whether Optimized Sweet Procedure is superior than the Ivor-Lewis Procedure Esophagectomy with better long-term outcome and acceptable postoperative short-term outcome or not. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophagogastric Junction Carcinoma
- What is being tested?
- Esophagectomy by Ivor-Lewis Procedure and Esophagectomy by Optimized Sweet Procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 30 Jun 2028
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Preoperative diagnosis confirmed by esophagogastroduodenoscopy showing an Esophagogastric junction mass, with histopathological confirmation of malignancy, specifically Siewert Type II;
- Preoperative blood pressure controlled below 160/100 mmHg, blood glucose levels within 5.6 to 11.2 mmol/L, and normal functioning of major organs such as heart, lungs, liver, and kidneys. Main criteria include a Goldman cardiac risk index of grade 1 or 2; pulmonary function tests indicating predicted postoperative forced expiratory volume in 1 second (FEV1) > 40%, and carbon monoxide diffusion capacity (DLCO) ≥ 40%; total bilirubin < 1.5 times the upper limit of normal; Alanine amioTransferase (ALT) and Aspartate Transaminase (AST) < 2.5 times the upper limit of normal; creatinine ≤ 1.25 times the upper limit of normal and creatinine clearance ≥ 60 mL/min;
- Enhanced thin-slice CT scan of the thorax and abdomen showing a tumor with a maximum diameter not exceeding 5 cm, and lymph nodes in the thorax and abdomen with a short diameter not exceeding 1 cm, clinically staged as CT1-2N0-1M0 (8th edition JACC staging);
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1;
- All relevant examinations completed within 14 days before surgery;
- Patients capable of understanding the study and providing informed consent by signing the consent form.
Who cannot join
- Patients who have undergone prior anti-tumor therapy (such as radiotherapy, chemotherapy, immunotherapy, etc.) before surgery; individuals with a history of other malignancies; patients presenting with secondary primary cancer at the time of enrollment; those with a history of prior unilateral thoracic or abdominal major surgeries; pregnant or lactating women; individuals with interstitial pneumonia, pulmonary fibrosis, or severe emphysema; uncontrolled infections; severe mental illness; and those with a history of severe heart disease, congestive heart failure, myocardial infarction, or angina attacks within the last six months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu
Louqian Zhang, MD, zhanglouqian@njmu.edu.cn
Rulin Zhuang, MD,PhD, rulinzhuang@njmu.edu.cn
About this study
Official title: A Randomized Controlled Study of Optimized Sweet Procedure Versus Ivor-Lewis Procedure Esophagectomy in Adenocarcinoma of Esophagogastric Junction
This study is being done to see whether Optimized Sweet Procedure is superior than the Ivor-Lewis Procedure Esophagectomy with better long-term outcome and acceptable postoperative short-term outcome or not.
Read the detailed description
Esophagogastric junction carcinoma is a prevalent malignancy within the human digestive system, ranking as the sixth leading cause of cancer-related deaths worldwide. Current national and international guidelines advocate for a comprehensive approach primarily centered around surgical intervention for the management of esophagogastric junction carcinoma. This preference stems from the fact that lymph node metastasis in such patients can occur simultaneously in the abdominal region and the lower mediastinum. Consequently, conventional options like the Ivor Lewis and Sweet procedures are routinely recommended due to their capability to encompass tumor resection, margin clearance, and lymph node dissection. However, traditional Sweet procedures are associated with higher surgical trauma and increased postoperative complications. With the evolution of single-incision thoracoscopy, we have leveraged the advantages of minimally invasive techniques and innovatively devised an Optimized "totally thoracoscopic Sweet procedure".In this study, a randomized controlled trial will enroll 240 patients diagnosed with esophagogastric junction carcinoma to compare the therapeutic efficacy between the Optimized Sweet Procedure and the Ivor-Lewis Procedure. Postoperative follow-ups will be conducted to analyze pre-discharge indicators and five-year postoperative outcomes, examining the correlation between the two surgical procedures in terms of postoperative quality of life, mortality rates, and survival rates, aiming to explore whether the Optimized Sweet Procedure is superior to the Ivor-Lewis Procedure Esophagectomy.
- Conditions
- Esophagogastric Junction Carcinoma
- Being tested
- Esophagectomy by Ivor-Lewis Procedure, Esophagectomy by Optimized Sweet Procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophagectomy by Ivor-Lewis ProcedureProcedure or surgery
Esophagectomy was conducted by Ivor-Lewis Procedure.
Esophagectomy by Optimized Sweet ProcedureProcedure or surgery
Esophagectomy was conducted by Optimized Sweet Procedure.
| Study group | Role | What they receive |
|---|---|---|
| Ivor-Lewis Procedure | Active comparator | Arm A: Esophagectomy was conducted through right side thoracotomy plus midline laparotomy approach: Ivor-Lewis Procedure. Receives: Procedure: Esophagectomy by Ivor-Lewis Procedure |
| Optimized Sweet Procedure | Active comparator | Arm B: Esophagectomy was conducted by single-incision thoracoscope combined with laparoscopy with the patient in a right oblique side position at 45 degrees: Optimized Sweet Procedure. Receives: Procedure: Esophagectomy by Optimized Sweet Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival
Measured: 5 years
Secondary outcomes (4)
Overall survival
Measured: 5 years
Postoperative morbidity
Measured: 3 years
Postoperative mortality
Measured: 3 years
locoregional recurrence
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start1 Dec 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagogastric Junction CarcinomaStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louqian Zhang, MD, Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162767
- Sponsor's protocol ID
- 2023-186-02
- Status last verified
- Jun 2023
- First submitted
- 14 Nov 2023
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Optimized Sweet Procedure Versus Ivor-Lewis Procedure Esophagectomy in Adenocarcinoma of Esophagogastric Junction
- ClinicalTrials.gov ID
- NCT06162767
- Acronym / sponsor ID
- 2023-186-02
- Conditions
- Esophagogastric Junction Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 8 Dec 2023 (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.
This study is being done to see whether Optimized Sweet Procedure is superior than the Ivor-Lewis Procedure Esophagectomy with better long-term outcome and acceptable postoperative short-term outcome or not.
Detailed description
Esophagogastric junction carcinoma is a prevalent malignancy within the human digestive system, ranking as the sixth leading cause of cancer-related deaths worldwide. Current national and international guidelines advocate for a comprehensive approach primarily centered around surgical intervention for the management of esophagogastric junction carcinoma. This preference stems from the fact that lymph node metastasis in such patients can occur simultaneously in the abdominal region and the lower mediastinum. Consequently, conventional options like the Ivor Lewis and Sweet procedures are routinely recommended due to their capability to encompass tumor resection, margin clearance, and lymph node dissection. However, traditional Sweet procedures are associated with higher surgical trauma and increased postoperative complications. With the evolution of single-incision thoracoscopy, we have leveraged the advantages of minimally invasive techniques and innovatively devised an Optimized "totally thoracoscopic Sweet procedure".In this study, a randomized controlled trial will enroll 240 patients diagnosed with esophagogastric junction carcinoma to compare the therapeutic efficacy between the Optimized Sweet Procedure and the Ivor-Lewis Procedure. Postoperative follow-ups will be conducted to analyze pre-discharge indicators and five-year postoperative outcomes, examining the correlation between the two surgical procedures in terms of postoperative quality of life, mortality rates, and survival rates, aiming to explore whether the Optimized Sweet Procedure is superior to the Ivor-Lewis Procedure Esophagectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ivor-Lewis Procedure | Active comparator | Procedure: Esophagectomy by Ivor-Lewis ProcedureArm A: Esophagectomy was conducted through right side thoracotomy plus midline laparotomy approach: Ivor-Lewis Procedure. |
| Optimized Sweet Procedure | Active comparator | Procedure: Esophagectomy by Optimized Sweet ProcedureArm B: Esophagectomy was conducted by single-incision thoracoscope combined with laparoscopy with the patient in a right oblique side position at 45 degrees: Optimized Sweet Procedure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Preoperative diagnosis confirmed by esophagogastroduodenoscopy showing an Esophagogastric junction mass, with histopathological confirmation of malignancy, specifically Siewert Type II;
- Preoperative blood pressure controlled below 160/100 mmHg, blood glucose levels within 5.6 to 11.2 mmol/L, and normal functioning of major organs such as heart, lungs, liver, and kidneys. Main criteria include a Goldman cardiac risk index of grade 1 or 2; pulmonary function tests indicating predicted postoperative forced expiratory volume in 1 second (FEV1) > 40%, and carbon monoxide diffusion capacity (DLCO) ≥ 40%; total bilirubin < 1.5 times the upper limit of normal; Alanine amioTransferase (ALT) and Aspartate Transaminase (AST) < 2.5 times the upper limit of normal; creatinine ≤ 1.25 times the upper limit of normal and creatinine clearance ≥ 60 mL/min;
- Enhanced thin-slice CT scan of the thorax and abdomen showing a tumor with a maximum diameter not exceeding 5 cm, and lymph nodes in the thorax and abdomen with a short diameter not exceeding 1 cm, clinically staged as CT1-2N0-1M0 (8th edition JACC staging);
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1;
- All relevant examinations completed within 14 days before surgery;
Key exclusion criteria (1 listed)
- Patients who have undergone prior anti-tumor therapy (such as radiotherapy, chemotherapy, immunotherapy, etc.) before surgery; individuals with a history of other malignancies; patients presenting with secondary primary cancer at the time of enrollment; those with a history of prior unilateral thoracic or abdominal major surgeries; pregnant or lactating women; individuals with interstitial pneumonia, pulmonary fibrosis, or severe emphysema; uncontrolled infections; severe mental illness; and those with a history of severe heart disease, congestive heart failure, myocardial infarction, or angina attacks within the last six months.
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 |
|---|---|---|
| Esophagectomy by Ivor-Lewis ProcedureEsophagectomy was conducted by Ivor-Lewis Procedure. | Procedure or surgery | Ivor-Lewis Procedure |
| Esophagectomy by Optimized Sweet ProcedureEsophagectomy was conducted by Optimized Sweet Procedure. | Procedure or surgery | Optimized Sweet Procedure |
Primary outcome
Disease Free Survival
Time frame: 5 years
4 secondary outcomes
Overall survival
Time frame: 5 years
Postoperative morbidity
Time frame: 3 years
Postoperative mortality
Time frame: 3 years
locoregional recurrence
Time frame: 5 years
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 21 Mar 2024.
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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.
Louqian Zhang, MD principal investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esophagectomy by Ivor-Lewis Procedure and Esophagectomy by Optimized Sweet Procedure in people with Esophagogastric Junction Carcinoma, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
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 6 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 21 Mar 2024. 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 China. 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 Louqian Zhang, MD (+86-02556682004, zhanglouqian@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Free Survival (time frame: 5 years). 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 21 Mar 2024.