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

NCT02005809 | Unknown Phase 3 DMC

• 1 other identifier: 2nd look EGD
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Neoplasms

Keywords

Endoscopic submucosal dissection; gastric neoplasm; second look endoscopy

Outcome Measures

Primary Outcomes (1)

• Post-ESD bleeding rate according to second look endoscopy

  Up to 60days

Secondary Outcomes (4)

• bleeding complication rate according to location of lesion in stomach.

  Up to 60days

• Bleeding rate according to size of resected specimen

  Up to 60days

• Post ESD bleeding rate according to total procedure time of endoscopic submucosal dissection

  Up to 60days

• Post ESD bleeding rate according to bleeding degree during endoscopic submucosal dissection

  Up to 60days

Study Arms (2)

Second look endoscopy

ACTIVE COMPARATOR

This group is performed second look endoscopy about 24 hours later from endoscopic submucosal dissection.

Procedure: second look endoscopy

without second look endoscopy

NO INTERVENTION

This group is not performed second look endoscopy after ESD

Interventions

second look endoscopy PROCEDURE

Second look endoscopy includes observation or prophylactic bleeding control of ESD site.

Second look endoscopy

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kosin University Gospel Hospital: lead
• Inje University: collaborator

Study Sites (1)

Kosin University Gospel Hospital

Busan, 602-702, South Korea

RECRUITING

Related Publications (12)

• 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. doi: 10.1055/s-2001-12805.

  PMID: 11293753 BACKGROUND

• 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.

  PMID: 9427030 BACKGROUND

• 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.

  PMID: 19922919 BACKGROUND

• 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. doi: 10.3748/wjg.v16.i23.2913.

  PMID: 20556838 BACKGROUND

• 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.

  PMID: 18322872 BACKGROUND

• 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. doi: 10.1097/MEG.0b013e32801015be.

  PMID: 17413293 BACKGROUND

• 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. doi: 10.1111/j.1572-0241.2007.01197.x. Epub 2007 Mar 31.

  PMID: 17403076 BACKGROUND

• 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.

  PMID: 19249769 BACKGROUND

• 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. doi: 10.1007/pl00011720.

  PMID: 11984739 BACKGROUND

• 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. doi: 10.1136/gut.48.2.225.

  PMID: 11156645 BACKGROUND

• 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.

  PMID: 19098667 BACKGROUND

• 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. doi: 10.1007/s10620-005-2760-0.

  PMID: 16047460 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Moo In Park, MD

CONTACT

82519905061; myjuyoung@hanmail.net

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of internal medicine, Kosin University Gospel Hospital

Study Record Dates

• First Submitted: November 26, 2013
• First Posted: December 9, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: December 9, 2013

Record last verified: 2013-12

Locations

KR (1)