Clinical trial · Interventional
Cancer of Esophagogastric Junction: Optimized Sweet Versus Ivor-Lewis
A Randomized Controlled Study of Optimized Sweet Procedure Versus Ivor-Lewis Procedure Esophagectomy in Adenocarcinoma of Esophagogastric Junction
NCT06162767CI-TRIAL-00075268recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophagogastric Junction Carcinoma | Gastroesophageal Junction Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Esophagectomy by Ivor-Lewis Procedure | Procedure | — | UNRESOLVED |
| Esophagectomy by Optimized Sweet Procedure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Ivor-Lewis Procedure
- description
- Arm A: Esophagectomy was conducted through right side thoracotomy plus midline laparotomy approach: Ivor-Lewis Procedure.
- interventionNames
- Procedure: Esophagectomy by Ivor-Lewis Procedure
- type
- ACTIVE_COMPARATOR
- label
- Optimized Sweet Procedure
- description
- 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.
- interventionNames
- Procedure: Esophagectomy by Optimized Sweet Procedure
Primary outcomes (1)
- measure
- Disease Free Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Preoperative diagnosis confirmed by esophagogastroduodenoscopy showing an Esophagogastric junction mass, with histopathological confirmation of malignancy, specifically Siewert Type II; 2. 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; 3. 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); 4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1; 5. All relevant examinations completed within 14 days before surgery; 6. Patients capable of understanding the study and providing informed consent by signing the consent form. Exclusion Criteria: 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.
References
Publications (0)
Data not yet available
No reference posted for this study.