Early Gastric Cancer Clinical Trial
Verified date | December 2016 |
Source | Yonsei University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Endoscopic submucosal dissection (ESD) is an advanced technique that enables en bloc resection of superficial tumors in the gastrointestinal tract. ESD, however, is a time-consuming procedure that requires a high level of endoscopic skill to achieve a desirable oncologic outcome. Several procedure-related complications may occur after ESD. Especially, iatrogenic ulcer bleeding after ESD can be a concern for both endoscopists and patients. In order to reduce the bleeding rate, proton pump inhibitors (PPIs) are administered after ESD. In addition, ulcer protective agents such as rebamipide can be added to PPIs for accelerating ulcer healing. We aimed to evaluate the efficacy of polaprezinc for healing of iatrogenic ulcer.
Status | Completed |
Enrollment | 153 |
Est. completion date | April 14, 2016 |
Est. primary completion date | April 14, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 79 Years |
Eligibility |
Inclusion Criteria: 1. Age, between 19 and 79 2. Patients with gastric adenoma or early gastric cancer 3. Patients with ECOG-PS 0 or 1 4. Patients with adequate renal function 5. Patients with adequate hepatic function 6. Patients with adequate bone marrow function Exclusion Criteria: 1. Patients who has taken the medications for ulcer including PPIs, H2 blockers, and mucosal protective agents within 3 months prior to the ESD. 2. Patients who has taken steroid or NSAIDswithin 3 months prior to the ESD. 3. Patients who has undergone gastrostomy 4. Patients with allergy for pantoprazole, polaprezinc, or rebamipide. 5. Pregnant or breast feeding. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Sevrance hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ulcering healing rate | Healing rate of the iatrogenic ulcer according to the type of ulcer protective agents (polaprezinc vs. rebamipide). | 4 weeks after the ESD | |
Secondary | Scarring change rate | Scarring change rate of the iatrogenic ulcer according to the type of ulcer protective agents (polaprezinc vs. rebamipide). | 4 weeks after the ESD |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT04977401 -
EndoscoPic Submucosal dIssection Using geL Versus glycerOl for Submucosal iNjection
|
N/A | |
Not yet recruiting |
NCT04083573 -
Comparison of Diagnostic Performance of Medical Monitor and Medical Augmented Reality Glasses in Endoscopy: Observation Study
|
||
Completed |
NCT02504164 -
Effect of Midazolam Premedication on the Satisfaction Levels of Patients After Endoscopic Submucosal Dissection
|
N/A | |
Recruiting |
NCT01774266 -
Detection of Methylated Reprimo in Plasma for Asymptomatic Gastric Cancer
|
N/A | |
Completed |
NCT01921283 -
Monitored Anesthesia Care With Propofol Plus Remifentanil During Endoscopic Submucosal Dissection: Evaluation of Bispectral Index Monitoring
|
N/A | |
Completed |
NCT01435525 -
Nexium Capsules Helicobacter Pylori Specific Clinical Experience Investigation
|
N/A | |
Completed |
NCT01364324 -
Pharmacokinetics of Anti-tuberculosis Drugs in Gastrectomized Patients
|
||
Recruiting |
NCT03837301 -
Non-exposure Simple Suturing EFTR (NESS-EFTR) With Laparoscopic Sentinel Lymph Node Navigation for EGC (Senorita3-phase 2)
|
Phase 2 | |
Recruiting |
NCT05269056 -
Early Detection of Gastric Cancer Using Plasma Cell-free DNA Fragmentomics
|
||
Not yet recruiting |
NCT03632746 -
Verifying the Specificity of a New Method in Predicting Lymph Node Metastasis in Early Gastric Cancer Patients
|
||
Completed |
NCT01938326 -
Pure Single Incision Laparoscopic Distal Gastrectomy (SIDG) Versus Totally Laparoscopic Distal Gastrectomy (TLDG)
|
N/A | |
Recruiting |
NCT04602689 -
Fibrin Glue After ESD for High Risk Patients of Bleeding
|
N/A | |
Recruiting |
NCT05291728 -
Screening for Early Gastric Cancer in Shaanxi Province
|
||
Not yet recruiting |
NCT06152783 -
Confocal Laser Microendoscopy (CellTouch) for the Diagnosis of Early Gastric Cancer: A Multicenter Clinical Study
|
||
Completed |
NCT02189226 -
Usefulness of Probe-based Confocal Laser Endo-microscopy in Delineation of Margin of Early Gastric Cancer for Endoscopic Submucosal Dissection
|
N/A | |
Completed |
NCT04602299 -
Setting the Shortest Examination Time of Gastroscopy to Improve the Detection Rate of Upper Gastrointestinal Tumors
|
N/A | |
Completed |
NCT02562976 -
OLGA Stage is More Appropriate in Predicting Early Gastric Cancer
|
N/A | |
Recruiting |
NCT01132469 -
Efficacy and Safety Study of Endoscopic Submucosal Dissection for Early Gastric Cancer
|
N/A | |
Completed |
NCT03136354 -
Prospective Randomized Trial Comparing Endoscopic Submucosal Dissection Against Laparoscopic Assisted Gastrectomy for Treatment of Early Gastric Cancer
|
N/A | |
Completed |
NCT02216110 -
Endoscopic Submucosal Dissection Versus Gastrectomy
|
N/A |