Clinical trial NCT02005809: Clinical Impact of Second-look Endoscopy After Endoscopic Submucosal Dissection of Gastric Neoplasm
Official title: Clinical Impact of Second-look Endoscopy After Endoscopic Submucosal Dissection of Gastric Neoplasm
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Gastric Neoplasms
Keywords: Endoscopic submucosal dissection
gastric neoplasm
second look endoscopy
Lead sponsor: Kosin University Gospel Hospital
Sponsor class: OTHER
Collaborators: name: Inje University
First posted: 2013-12-09
Enrollment: 268
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Gastroenterologists often follow up second look endoscopy after endoscopic submucosal dissection(ESD) of gastric neoplasms because they want to prevent bleeding of procedure sites. But Goto suggested in his retrospective analysis that a second-look endoscopy after endoscopic submucosal dissection for gastric epithelial neoplasm may be unnecessary. So, the investigators try to identify the hypothesis prospectively in this study.


Eligibility criteria: Inclusion Criteria:

* histological confirmed patients(gastric adenoma or adenocarcinoma)
* performed gastric ESD patients about 24 hours before

Exclusion Criteria:

* perforation after ESD
* piecemeal resection of ESD specimen
* hemostatic agent or proton pump inhibitor users before ESD
* heparin or antiplatelet agent users
* Serious concurrent infection or nonmalignant illness that is uncontrolled
* Psychiatric disorder that would preclude compliance
* Allergy history to proton pump inhibitor

Primary outcomes:
measure: Post-ESD bleeding rate according to second look endoscopy
timeFrame: Up to 60days
Secondary outcomes:
measure: bleeding complication rate according to location of lesion in stomach.
timeFrame: Up to 60days
measure: Bleeding rate according to size of resected specimen
timeFrame: Up to 60days
measure: Post ESD bleeding rate according to total procedure time of endoscopic submucosal dissection
timeFrame: Up to 60days
measure: Post ESD bleeding rate according to bleeding degree during endoscopic submucosal dissection
timeFrame: Up to 60days
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
Study officials:
References:
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