Clinical trial · Observational
Endoscopic Submucosal Dissection Registry
Establishment of Registry for Endoscopic Submucosal Dissection for Superficial Gastrointestinal Neoplasia
NCT01415609CI-TRIAL-00008453ESD RegistrycompletedClinicalTrials.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)
The purpose of this study is to monitor the success rates and completion rates for endoscopic submucosal dissection (ESD) for gastrointestinal (GI) cancers.
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 |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastrointestinal Neoplasms | Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Ease of use of the overall procedure and Time of procedure.
- timeFrame
- 1 Year
- description
- * Ease of use of overall procedure as rated on a 5-point visual analog scale for very easy, easy, neutral, difficult and very difficult. * Time (in minutes) needed to resect the lesion completely, as measured from the first injection to final excision of the lesion.
Secondary outcomes (1)
- measure
- Complications and Rate of Completion
- timeFrame
- 1 Year
- description
- * Minor and Major Bleeding * Minor and Major perforation * Post-polypectomy syndrome (defined as the presence of moderate or severe pain persisting more than 2 hours following completion of the procedure). * Other(any other adverse event which the investigator feels is potentially attributable to the procedure). * Enbloc resection of all endoscopically visible neoplasia * Pathologically negative for lateral and/or deep margins * Absence of residual neoplasia confirmed by repeat standard colonscopy and biopsy of ESD site 3-6 months following the index procedure.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Patients referred for endoscopic treatment of advanced gastrointestinal (colorectal, gastric, duodenal, esophagus) neoplasia, defined by any of the following procedures: 1. Flat dysplastic lesion greater than 2cm(IIa or IIb by Paris classification) 2. Flat depressed lesion \< 2cm in size (llc by Paris Classification) 3. Ulcerated lesion \< 2cm (Paris type lll) staged as T1N0 on endoscopic ultrasound 4. Upon resection, the criteria for curative ESD include: * Non-invasive neoplasia of differentiated carcinoma * No lymphovascular invasion * Intramucosal cancer or minute submucosal cancer \<1 mm invasion (sm1) * Negative deep and lateral margins. Exclusion Criteria: 1. Use of antiplatelet(e.g. clopidrogel) or anticoagulation (e.g. Coumadin) agents that cannot be withheld for at least 7 days prior to the procedure. Aspirin use is accepted according to the American Society for Gastrointestinal Endoscopy for these procedures. 2. Patients who refuse or who are unable to consent. 3. Suboptimal colon prep, or solid gastric residual that precludes safe lesion resection at the time of endoscopy. 4. Lesion location in a segment of the colon not conducive to ESD, including significant narrowing, tortuosity and/or extensive diverticular disease, as determined by the endoscopist.
References
Publications (0)
Data not yet available
No reference posted for this study.