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This will be a single-centre, randomised, endoscopist-blind, parallel-group study in patients who are scheduled endoscopic submucosal dissection (ESD) for gastric mucosal lesion. The primary objective is to observe whether a regimen of 7-day oral esomeprazole premedication can alleviate intraoperative bleeding in patients scheduled for ESD due to gastric mucosal lesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | No PPI treatment should given after the initial allocation. Patient will be admitted, and ESD will be performed. Then a 3-day i.v. treatment of esomeprazole will be initiated after ESD procedure and followed by a 26 days oral treatment with esomeprazole tablets 40 mg. |
|
| Esomeprazole group | Experimental | Esomeprazole should start as soon as possible after the initial allocation. During the 7 days of p.o. treatment, patient will be admitted, and ESD will be performed as soon as completing the p.o. treatment. Then a 3-day i.v. treatment of esomeprazole will be initiated after ESD procedure and followed by a 26 days oral treatment with esomeprazole tablets 40 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole | Drug | Proton pump inhibitor |
| |
| No PPI treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The total bleeding rate according to grading of intraoperative bleeding during ESD procedure | ≥grade 1 means bleeding | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| The frequency of coagrasper usage which reflects grade of major bleeding | 1 day | |
| Post-ESD ulcer quality as indicated in description | Ulcer base quality will be evaluated base on the grading of clean, with minor trace of coagulation, base with extensive coagulation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhiguo Liu | Xijing Hospital of Digestive Disease | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital of Digestive Diseases | Xi'an | Shaanxi | 710032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21741645 | Background | Ahn JY, Jung HY, Choi KD, Choi JY, Kim MY, Lee JH, Choi KS, Kim DH, Song HJ, Lee GH, Kim JH, Park YS. Endoscopic and oncologic outcomes after endoscopic resection for early gastric cancer: 1370 cases of absolute and extended indications. Gastrointest Endosc. 2011 Sep;74(3):485-93. doi: 10.1016/j.gie.2011.04.038. Epub 2011 Jul 13. | |
| 23765426 |
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Paper publishing
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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| Drug |
No PPI treatment before ESD procedure |
|
| 1 day |
| Intra-procedure injury to muscularis propria including perforation. | Injury of muscularis propria will be evaluated as no injury, minor injury and deep injury/perforation. | 1 day |
| Mean haemoglobin reduction between intervention and control group. | 1 day |
| Delayed bleeding rate as indicated by haematemesis and melaena | 30 days |
| The mean percentage of mucosal defect reduction at follow-up endoscopy on 28 days after ESD procedure. | 30 days |
| Choi MK, Kim GH, Park DY, Song GA, Kim DU, Ryu DY, Lee BE, Cheong JH, Cho M. Long-term outcomes of endoscopic submucosal dissection for early gastric cancer: a single-center experience. Surg Endosc. 2013 Nov;27(11):4250-8. doi: 10.1007/s00464-013-3030-4. Epub 2013 Jun 14. |
| 20623442 | Background | Deprez PH, Bergman JJ, Meisner S, Ponchon T, Repici A, Dinis-Ribeiro M, Haringsma J. Current practice with endoscopic submucosal dissection in Europe: position statement from a panel of experts. Endoscopy. 2010 Oct;42(10):853-8. doi: 10.1055/s-0030-1255563. Epub 2010 Jul 9. |
| 23368844 | Background | Fujishiro M, Chiu PW, Wang HP. Role of antisecretory agents for gastric endoscopic submucosal dissection. Dig Endosc. 2013 Mar;25 Suppl 1:86-93. doi: 10.1111/j.1443-1661.2012.01370.x. Epub 2013 Jan 24. |
| 10502182 | Background | Gotoda T, Kondo H, Ono H, Saito Y, Yamaguchi H, Saito D, Yokota T. A new endoscopic mucosal resection procedure using an insulation-tipped electrosurgical knife for rectal flat lesions: report of two cases. Gastrointest Endosc. 1999 Oct;50(4):560-3. doi: 10.1016/s0016-5107(99)70084-2. No abstract available. |
| 19891589 | Background | Jang JS, Choi SR, Graham DY, Kwon HC, Kim MC, Jeong JS, Won JJ, Han SY, Noh MH, Lee JH, Lee SW, Baek YH, Kim MJ, Jeong DS, Kim SK. Risk factors for immediate and delayed bleeding associated with endoscopic submucosal dissection of gastric neoplastic lesions. Scand J Gastroenterol. 2009;44(11):1370-6. doi: 10.3109/00365520903194609. |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |