Clinical trial · Interventional
Endoscopic Submucosal Dissection Versus Laparoscopic Resection for Early Colorectal Neoplasms
Endoscopic Submucosal Dissection Versus Laparoscopic Resection for Early Colorectal Neoplasms: A Prospective Randomized Trial
NCT01112046CI-TRIAL-00013721unknownPhase 3ClinicalTrials.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 is a prospective randomized trial that aimed to compare the short-term clinical outcomes and systemic inflammatory/cytokine responses of endoscopic submucosal dissection versus laparoscopic resection for early colorectal neoplasms that are not amenable to en bloc endoscopic resection with conventional techniques.
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 |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic submucosal dissection | Procedure | — | UNRESOLVED |
| Laparoscopic resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Endoscopic submucosal dissection
- interventionNames
- Procedure: Endoscopic submucosal dissection
- type
- ACTIVE_COMPARATOR
- label
- Laparoscopic resection
- interventionNames
- Procedure: Laparoscopic resection
Primary outcomes (1)
- measure
- Short-term morbidity
- timeFrame
- Up to 1 month
Secondary outcomes (5)
- measure
- Systemic cytokine and C-reactive protein levels
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients diagnosed with early colorectal neoplasms \>/= 2 cm in size in the colon or upper rectum (\>/= 15 cm above the anal verge) that are deemed not feasible for en bloc resection with conventional polypectomy or EMR as judged by 2 experienced endoscopists, * Age of patients \>18 years, * Patients with American Society of Anesthesiologists (ASA) grading I-III, * Informed consent available Exclusion Criteria: * Presence of endoscopic signs of massive submucosal invasion (including excavated/depressed morphology or Kudo's pit pattern Type V), * Endosonographic evidence of deep invasion, * Unfavorable histopathologic features on biopsy (including mucinous cancer, poor differentiation, and gross submucosal invasion), * Patients with other synchronous colorectal neoplasms in addition to the index neoplasm that are not amenable to complete endoscopic removal, neoplasms occupying more than half circumference of the colonic wall, * Patients with recurrence from previous endoscopic mucosal resection or ESD, * Patients with known metastatic disease, * Patients with previous history of abdominal surgery, and patients with non-correctable coagulopathy
References
Publications (0)
Data not yet available
No reference posted for this study.