Clinical trial · Interventional
Prospective Randomized Trial Comparing Endoscopic Submucosal Dissection Against Laparoscopic Assisted Gastrectomy for Treatment of Early Gastric Cancer
- 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)
The investigators compared the perioperative, oncological, functional and immunological outcomes of endoscopic submucosal dissection against laparoscopic assisted gastrectomy for treatment of early gastric cancer. With virtually no abdominal incisions and minimal pain induced, endoscopic submucosal dissection is expected to be less invasive when compared to laparoscopic assisted gastrectomy for treatment of early gastric cancer. This study will show that endoscopic submucosal dissection is associated with a significantly better perioperative recovery and less immunological disturbance. Moreover, it will also induce a better long term outcomes as the stomach can be preserved, hence the digestive function is maintained to prevent long term functional morbidities of the gastrointestinal tract. This study will be the unique first study in the literature to show that intramucosal early gastric cancer can be adequately treated by endoscopic submucosal dissection with better perioperative, functional and quality of life outcomes when compared to laparoscopic assisted gastrectomy.
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 |
|---|---|---|---|
| Early Gastric Cancer | Early Gastric Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic Submucosal Dissection | Procedure | — | UNRESOLVED |
| Laparoscopic assisted Gastrectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- ESD Group
- description
- Endoscopic Submucosal Dissection
- interventionNames
- Procedure: Endoscopic Submucosal Dissection
- type
- ACTIVE_COMPARATOR
- label
- LAG Group
- description
- Laparoscopic Assisted Gastrectomy
- interventionNames
- Procedure: Laparoscopic assisted Gastrectomy
Primary outcomes (1)
- measure
- Complication
- timeFrame
- 30 days after procedure
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Early gastric cancer with biopsy confirmed high grade dysplasia or adenocarcinoma (intestinal type) 2. Preoperative investigation with magnifying endoscopy and / or EUS predicted to be mucosal lesion 3. Any tumor size if the early gastric cancer has no ulceration 4. Tumor size ≤ 3cm if the early gastric cancer has ulceration Exclusion Criteria: 1. Gastric cancer with preoperative magnifying endoscopy and / or EUS predicted to beyond submucosal invasion 2. Poorly differentiated or signet ring cell adenocarcinoma 3. Age \> 80 or \< 16 4. Pregnancy 5. ASA \> IV
References
Publications (0)
Data not yet available