Hemostatic Forceps vs. Bipolar Electrocautery Probes for High-Risk Bleeding Gastroduodenal Ulcers
NCT ID: NCT06393907
Last Updated: 2024-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2024-03-26
2026-04-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Hemostatic forceps
Hemostatic forceps will be used for control bleeding with electrocautery unit setting: 80 W, effect 4, soft coagulation mode for 1-2 seconds.
Hemostatic Forceps
The experimental device will be used for control bleeding in high risk gastroduodenal ulcers.
Bipolar electrocautery probes
Bipolar electrocautery probes will be used for control bleeding with electrocautery unit setting: effect 2, soft coagulation bipolar mode for 8-10 seconds.
Bipolar Electrocautery Probes
The active comparator devices will be used for control bleeding in high risk gastroduodenal ulcers.
Interventions
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Hemostatic Forceps
The experimental device will be used for control bleeding in high risk gastroduodenal ulcers.
Bipolar Electrocautery Probes
The active comparator devices will be used for control bleeding in high risk gastroduodenal ulcers.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The patient with gastroduodenal ulcer with indication for hemostatic intervention including 2.1 Forrest classification 1a (Active spurting) 2.2 Forrest classification 1b (Active oozing) 2.3 Forrest classification 2a (Non-bleeding visible vessel; NBVV) 2.4 Forrest classification 2b (Adherent clot) with lesion underneath clot which need hemostatic intervention including active spurting, active oozing or non-bleeding visible vessel
Exclusion Criteria
2. Bleeding from cancerous gastroduodenal ulcer
3. The patient with history of gastric surgery
4. The patient with history of bleeding gastroduodenal ulcer within 30 days prior to enrollment
5. The patient with history of proton pump inhibitor allergy
6. Pregnant
7. The patient deny to participate in the study
18 Years
ALL
No
Sponsors
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Mahidol University
OTHER
Responsible Party
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Uayporn
Assistant professor
Principal Investigators
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Uayporn Kaosombatwattana, MD
Role: PRINCIPAL_INVESTIGATOR
Mahidol University
Locations
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Faculty of internal medicine siriraj hospital, Mahidol university
Bangkok Noi, Bangkok, Thailand
Countries
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Central Contacts
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Facility Contacts
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References
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Charatcharoenwitthaya P, Pausawasdi N, Laosanguaneak N, Bubthamala J, Tanwandee T, Leelakusolvong S. Characteristics and outcomes of acute upper gastrointestinal bleeding after therapeutic endoscopy in the elderly. World J Gastroenterol. 2011 Aug 28;17(32):3724-32. doi: 10.3748/wjg.v17.i32.3724.
Forrest JA, Finlayson ND, Shearman DJ. Endoscopy in gastrointestinal bleeding. Lancet. 1974 Aug 17;2(7877):394-7. doi: 10.1016/s0140-6736(74)91770-x. No abstract available.
ASGE technology committee; Parsi MA, Schulman AR, Aslanian HR, Bhutani MS, Krishnan K, Lichtenstein DR, Melson J, Navaneethan U, Pannala R, Sethi A, Trikudanathan G, Trindade AJ, Watson RR, Maple JT; ASGE Technology Committee Chair. Devices for endoscopic hemostasis of nonvariceal GI bleeding (with videos). VideoGIE. 2019 Jun 27;4(7):285-299. doi: 10.1016/j.vgie.2019.02.004. eCollection 2019 Jul.
Asge Technology Committee; Conway JD, Adler DG, Diehl DL, Farraye FA, Kantsevoy SV, Kaul V, Kethu SR, Kwon RS, Mamula P, Rodriguez SA, Tierney WM. Endoscopic hemostatic devices. Gastrointest Endosc. 2009 May;69(6):987-96. doi: 10.1016/j.gie.2008.12.251. No abstract available.
Arima S, Sakata Y, Ogata S, Tominaga N, Tsuruoka N, Mannen K, Shiraishi R, Shimoda R, Tsunada S, Sakata H, Iwakiri R, Fujimoto K. Evaluation of hemostasis with soft coagulation using endoscopic hemostatic forceps in comparison with metallic hemoclips for bleeding gastric ulcers: a prospective, randomized trial. J Gastroenterol. 2010 May;45(5):501-5. doi: 10.1007/s00535-009-0186-8. Epub 2009 Dec 25.
Kim JW, Jang JY, Lee CK, Shim JJ, Chang YW. Comparison of hemostatic forceps with soft coagulation versus argon plasma coagulation for bleeding peptic ulcer--a randomized trial. Endoscopy. 2015 Aug;47(8):680-7. doi: 10.1055/s-0034-1391565. Epub 2015 Mar 2.
Nunoue T, Takenaka R, Hori K, Okazaki N, Hamada K, Baba Y, Yamasaki Y, Kono Y, Seki H, Inokuchi T, Takemoto K, Taira A, Tsugeno H, Fujiki S, Kawahara Y, Okada H. A Randomized Trial of Monopolar Soft-mode Coagulation Versus Heater Probe Thermocoagulation for Peptic Ulcer Bleeding. J Clin Gastroenterol. 2015 Jul;49(6):472-6. doi: 10.1097/MCG.0000000000000190.
Toka B, Eminler AT, Karacaer C, Uslan MI, Koksal AS, Parlak E. Comparison of monopolar hemostatic forceps with soft coagulation versus hemoclip for peptic ulcer bleeding: a randomized trial (with video). Gastrointest Endosc. 2019 Apr;89(4):792-802. doi: 10.1016/j.gie.2018.10.011. Epub 2018 Oct 17.
Bianco MA, Rotondano G, Marmo R, Piscopo R, Orsini L, Cipolletta L. Combined epinephrine and bipolar probe coagulation vs. bipolar probe coagulation alone for bleeding peptic ulcer: a randomized, controlled trial. Gastrointest Endosc. 2004 Dec;60(6):910-5. doi: 10.1016/s0016-5107(04)02232-1.
Laine L, Jensen DM. Management of patients with ulcer bleeding. Am J Gastroenterol. 2012 Mar;107(3):345-60; quiz 361. doi: 10.1038/ajg.2011.480. Epub 2012 Feb 7.
Veitch AM, Radaelli F, Alikhan R, Dumonceau JM, Eaton D, Jerrome J, Lester W, Nylander D, Thoufeeq M, Vanbiervliet G, Wilkinson JR, Van Hooft JE. Endoscopy in patients on antiplatelet or anticoagulant therapy: British Society of Gastroenterology (BSG) and European Society of Gastrointestinal Endoscopy (ESGE) guideline update. Gut. 2021 Sep;70(9):1611-1628. doi: 10.1136/gutjnl-2021-325184.
Other Identifiers
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Si 223/2024
Identifier Type: -
Identifier Source: org_study_id
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