Clinical Impact of Second-look Endoscopy After Endoscopic Submucosal Dissection of Gastric Neoplasm

Gastric Neoplasms Clinical Trial

— SLEGD  

Official title:

Clinical Impact of Second-look Endoscopy After Endoscopic Submucosal Dissection of Gastric Neoplasm

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02005809
• Other study ID #: 2nd look EGD
• Status: Recruiting
• Phase: Phase 3
• First received: November 26, 2013
• Last updated: December 4, 2013
• Start date: March 2013
• Est. completion date: March 2015

Study information

• Verified date: December 2013
• Source: Kosin University Gospel Hospital
• Contact: Moo In Park, MD
• Phone: 82519905061
• Email: myjuyoung[@]hanmail.net
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 268
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Neoplasms
• Neoplasms
• Stomach Neoplasms

Intervention

Procedure:
• second look endoscopy
Second look endoscopy includes observation or prophylactic bleeding control of ESD site.

Locations

Country	Name	City	State
Korea, Republic of	Kosin University Gospel Hospital	Busan

Sponsors (2)

Lead Sponsor	Collaborator
Kosin University Gospel Hospital	Inje University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (12)

Chung IK, Lee JH, Lee SH, Kim SJ, Cho JY, Cho WY, Hwangbo Y, Keum BR, Park JJ, Chun HJ, Kim HJ, Kim JJ, Ji SR, Seol SY. Therapeutic outcomes in 1000 cases of endoscopic submucosal dissection for early gastric neoplasms: Korean ESD Study Group multicenter study. Gastrointest Endosc. 2009 Jun;69(7):1228-35. doi: 10.1016/j.gie.2008.09.027. Epub 2009 Feb 27. — View Citation

Fujishiro M, Kodashima S, Goto O, Ono S, Muraki Y, Kakushima N, Omata M. Technical feasibility of endoscopic submucosal dissection of gastrointestinal epithelial neoplasms with a splash-needle. Surg Laparosc Endosc Percutan Tech. 2008 Dec;18(6):592-7. doi: 10.1097/SLE.0b013e318187973f. — View Citation

Goto O, Fujishiro M, Kodashima S, Ono S, Niimi K, Hirano K, Yamamichi N, Koike K. A second-look endoscopy after endoscopic submucosal dissection for gastric epithelial neoplasm may be unnecessary: a retrospective analysis of postendoscopic submucosal dissection bleeding. Gastrointest Endosc. 2010 Feb;71(2):241-8. doi: 10.1016/j.gie.2009.08.030. Epub 2009 Nov 17. — View Citation

Gotoda T, Yanagisawa A, Sasako M, Ono H, Nakanishi Y, Shimoda T, Kato Y. Incidence of lymph node metastasis from early gastric cancer: estimation with a large number of cases at two large centers. Gastric Cancer. 2000 Dec;3(4):219-225. — View Citation

Kim JW, Kim HS, Park DH, Park YS, Jee MG, Baik SK, Kwon SO, Lee DK. Risk factors for delayed postendoscopic mucosal resection hemorrhage in patients with gastric tumor. Eur J Gastroenterol Hepatol. 2007 May;19(5):409-15. — View Citation

Ohkuwa M, Hosokawa K, Boku N, Ohtu A, Tajiri H, Yoshida S. New endoscopic treatment for intramucosal gastric tumors using an insulated-tip diathermic knife. Endoscopy. 2001 Mar;33(3):221-6. — View Citation

Ono H, Kondo H, Gotoda T, Shirao K, Yamaguchi H, Saito D, Hosokawa K, Shimoda T, Yoshida S. Endoscopic mucosal resection for treatment of early gastric cancer. Gut. 2001 Feb;48(2):225-9. — View Citation

Shimatani T, Inoue M, Kuroiwa T, Xu J, Tazuma S, Horikawa Y, Nakamura M. Acid-suppressive efficacy of a reduced dosage of rabeprazole: comparison of 10 mg twice daily rabeprazole with 20 mg twice daily rabeprazole, 30 mg twice daily lansoprazole, and 20 mg twice daily omeprazole by 24-hr intragastric pH-metry. Dig Dis Sci. 2005 Jul;50(7):1202-6. — View Citation

Takeshita K, Tani M, Inoue H, Saeki I, Honda T, Kando F, Saito N, Endo M. A new method of endoscopic mucosal resection of neoplastic lesions in the stomach: its technical features and results. Hepatogastroenterology. 1997 Nov-Dec;44(18):1602-11. — View Citation

Takizawa K, Oda I, Gotoda T, Yokoi C, Matsuda T, Saito Y, Saito D, Ono H. Routine coagulation of visible vessels may prevent delayed bleeding after endoscopic submucosal dissection--an analysis of risk factors. Endoscopy. 2008 Mar;40(3):179-83. doi: 10.1055/s-2007-995530. — View Citation

Tsuji Y, Ohata K, Ito T, Chiba H, Ohya T, Gunji T, Matsuhashi N. Risk factors for bleeding after endoscopic submucosal dissection for gastric lesions. World J Gastroenterol. 2010 Jun 21;16(23):2913-7. — View Citation

Uedo N, Takeuchi Y, Yamada T, Ishihara R, Ogiyama H, Yamamoto S, Kato M, Tatsumi K, Masuda E, Tamai C, Yamamoto S, Higashino K, Iishi H, Tatsuta M. Effect of a proton pump inhibitor or an H2-receptor antagonist on prevention of bleeding from ulcer after endoscopic submucosal dissection of early gastric cancer: a prospective randomized controlled trial. Am J Gastroenterol. 2007 Aug;102(8):1610-6. Epub 2007 Mar 31. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-ESD bleeding rate according to second look endoscopy		Up to 60days	No
Secondary	bleeding complication rate according to location of lesion in stomach.	Fundus, cardia, upper body, mid body, lower body, antrum anterior wall, posterior wall, great curvature, lesser curvature	Up to 60days	No
Secondary	Bleeding rate according to size of resected specimen	longest diameter of specimen: millimeter	Up to 60days	No
Secondary	Post ESD bleeding rate according to total procedure time of endoscopic submucosal dissection		Up to 60days	No
Secondary	Post ESD bleeding rate according to bleeding degree during endoscopic submucosal dissection	Mild: bleeding control time: <1/3 of total ESD procedure time. Moderate: bleeding control time: 1/3~1/2 of total ESD procedure time Severe: bleeding control time: >1/2 of total ESD procedure time	Up to 60days	No