Clinical trial · Interventional
Evaluation of Endoscopic Submucosal Dissection (ESD) Efficacy
- 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)
Superficial rectal tumors could be removed by ESD with two major advantages showed by the literature: high rate of monobloc resection and R0 resection. Hence, recurrence rate was lower than ERM therapy. This technique is actually performed routinely in Japan and experience is limited in Europe, with few data in the literature. This study is suggested to patients with superficial medium or distal rectal tumors. The lesion was identified and demarcated using white-light endoscopy, magnifying endoscopy, and chromoendoscopy. Then, marking around the lesions was performed. Local injection was made using injection needle, and then mucosal incision was performed around the lesion using endo-knives. Submucosal dissection was performed using endo-knives. Hemostasis and vessel coagulation were practiced using primary hemostatic forceps during the procedure. Follow-up is one year. For lesion with invasive carcinoma (vessel and lymphatic involvement, undifferentiated, free margin less than 1 mm), a surgical resection is performed. All the patients have an endoscopic control 3 months after ESD (rectosigmoidoscopy with biopsies): * For complete resection, an endoscopic control was performed at 1 year. * For incomplete resection, another endoscopic therapy was attempted (EMR) an endoscopic control was performed at 1 year. At one year, patient with incomplete resection have a surgical resection.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Endoscopic Submucosal Dissection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic submucosal dissection (ESD) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Endoscopic submucosal dissection (ESD)
- description
- Endoscopic submucosal dissection (ESD)
- interventionNames
- Procedure: Endoscopic submucosal dissection (ESD)
Primary outcomes (1)
- measure
- curative resection rate (3 month)
- timeFrame
- 3 months
- description
- Evaluate the curative R0 resection rate at 3 months without surgical therapy, in patients with superficial rectal tumours
Secondary outcomes (4)
- measure
- monobloc resection rate
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with superficial medium or distal rectal tumors more than 1 cm in size * Criteria for ESD were determined by the endoscopic characteristics and histological findings of biopsy specimens * Endoscopic ultrasonography (EUS) also was performed when the lesion was strongly suspected of submucosal invasion. * Age older than 18, younger than 85 years. Exclusion Criteria: * Lesion less than 10 mm in size * Pedundulated lesion * Suspicion of submucosal invasion (MRI or EUS) * Distant metastasis on CTscan * Coagulopathy * Pregnancy * Refusal to participate to the study or inability to consent
References
Publications (0)
Data not yet available