- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03065257
Endoscopic Resection Multicenter Registry
Endoscopic Resection: A Retrospective and Prospective Multicenter Registry
This is a retrospective and prospective multicenter registry to collect long-term data (1 year) on patients who have or will undergo Endoscopic resection such as EMR, ESD, EFTR, STER, etc. within the gastrointestinal tract for endoscopic treatment of early gastrointestinal neoplasms involving the resection of the superficial layers, mucosa and submucosa, of the tract wall.
Subjects will be consented for medical chart review.
The purpose of this retrospective and prospective registry is to assess long term data on efficacy, safety and clinical outcome of Endoscopic Resection within the gastrointestinal tract (1 year).
The registry will evaluate efficacy, technical feasibility, clinical outcome, safety profile and overall clinical management through medical chart review. The procedures the investigators are evaluating are all clinically indicated and will not be prescribed to someone to participate in this registry study.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Endoscopic resection can be an appropriate approach in early neoplasms, challenging adenomas or sub-epithelial lesions. Endoscopic resection can be considered as a less invasive approach than surgery. Moreover, endoscopic resection can be available to patients who are ineligible for surgery or who have refused more aggressive surgical intervention.
The study investigators would collect data on a large sample size of subjects undergoing various endoscopic resection procedures such as EMR (Endoscopic Mucosal Resection), ESD (Endoscopic submucosal dissection), STER (Submucosal tunneling endoscopic resection, and EFTR (Endoscopic full-thickness resection). Clinical metrics will be recorded including procedure times, length of follow-up, specific tumor characteristics, resection method, pathology results, procedural complications, additional therapy required, and disease-free survival time.
Currently, there is limited multi-center data on endoscopic resection outcomes in western populations.
Evaluation of these measurement would help the investigators compare them to conventional treatment modalities within current tertiary facilities; and consequently help the investigators identify appropriate treatment techniques and improve clinical management of patients at WCMC-NYPH.
The purpose of this retrospective and prospective registry is to assess long term data on efficacy, safety and clinical outcome of Endoscopic Resection within the gastrointestinal tract (1 year).
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
-
-
New York
-
New York, New York, Förenta staterna, 10065
- Rekrytering
- Weill Cornell Medical College
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Any patient who is considering undergoing endoscopic resection within 6 months, or has undergone clinically indicated endoscopic resection within the past 6 months
- Above or equal to 18 years of age.
Exclusion Criteria:
- Any patient who has not undergone or will undergo endoscopic resection
- Below 18 years of age.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Endoscopic Resection
Patients undergoing Endoscopic Resection
|
Any Endoscopic resection for Gastrointestinal disorders including neoplasms.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of participants with reduction in clinical symptoms
Tidsram: 6 months from procedure
|
To assess resolution of symptoms of all Endoscopic resection procedures at 6 months
|
6 months from procedure
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Tidsram: 30 days post procedure
|
Number of subjects with Adverse Events; Type, frequency and intensity of adverse events within 30 days of procedure
|
30 days post procedure
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of participants with successful completion of treatment
Tidsram: 30 days post procedure
|
Number of participants with successful completion of treatment
|
30 days post procedure
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter plats
- Magsjukdomar
- Neoplasmer i huvud och hals
- Kolonsjukdomar
- Tarmsjukdomar
- Patologiska tillstånd, anatomiska
- Intestinala neoplasmer
- Esofagussjukdomar
- Duodenal sjukdomar
- Kolorektala neoplasmer
- Neoplasmer
- Neoplasmer i magen
- Gastrointestinala sjukdomar
- Matsmältningssystemets sjukdomar
- Gastrointestinala neoplasmer
- Neoplasmer i matsmältningssystemet
- Polyper
- Esofagusneoplasmer
- Kolonneoplasmer
- Duodenala neoplasmer
Andra studie-ID-nummer
- 1701017930
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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