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A randomized controlled trial to evaluate the efficacy of hemostatic forceps and bipolar electrocautery probes in patient with high risk bleeding gastroduodenal ulcers.
This is a prospective randomized controlled trial to evaluate the efficacy of hemostatic forceps and bipolar electrocautery probes in patients with high-risk bleeding gastroduodenal ulcers. The primary outcome is comparing the hemostatic rates of the devices. Secondary outcomes are rebleeding rate at 7 and 30 days after index intervention, survival rate after intervention, procedure time for achieving hemostasis, number of units of infused blood, duration of hospitalization, and complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemostatic forceps | Experimental | Hemostatic forceps will be used for control bleeding with electrocautery unit setting: 80 W, effect 4, soft coagulation mode for 1-2 seconds. |
|
| Bipolar electrocautery probes | Active Comparator | Bipolar electrocautery probes will be used for control bleeding with electrocautery unit setting: effect 2, soft coagulation bipolar mode for 8-10 seconds. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemostatic Forceps | Device | The experimental device will be used for control bleeding in high risk gastroduodenal ulcers. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparing hemostatic rate between hemostatic forceps and bipolar electrocautery probes | When the bleeding stopped for at least 2 minutes, it is defined as successful hemostasis. | During esophagogastroduodenoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Rebleeding rate at 7 days and 30 days after index intervention | After primary hemostasis, patients will be follow up at 7 and 30 days for evidence of rebleeding. | 30 days |
| Survival rate after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Uayporn Kaosombattwattana, MD | Contact | +66619245953 | Koigi214@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Uayporn Kaosombatwattana, MD | Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of internal medicine siriraj hospital, Mahidol university | Recruiting | Bangkok Noi | Bangkok | 10700 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21990954 | Background | 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. | |
| 4136718 | Background |
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| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| ID | Term |
|---|---|
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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Hemostatic Forceps versus Bipolar Electrocautery Probes
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The participants will be randomized for each intervention using sequentially numbered, opaque sealed envelopes after recruitment in the study. The care provider who uses the devices cannot be blinded.
| Bipolar Electrocautery Probes | Device | The active comparator devices will be used for control bleeding in high risk gastroduodenal ulcers. |
|
|
Patients who live longer than 30 days after hemostasis will be counted for survival rate.
| 30 days |
| Procedure time for achieving hemostasis | Procedure time will be counted from the time of device insertion to the time of achieving hemostasis. | During esophagogastroduodenoscopy |
| Number of units of infused blood | Number of red cell units which are transfused to the patients. | 30 days |
| Duration of hospitalization | The length of hospital stay. | 30 days |
| Complications of hemostatic interventions | Complications related to intervention include perforation, infection, and organ failure | 30 days |
| 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. |
| 31334417 | Background | 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. |
| 19410037 | Background | 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. |
| 20033825 | Background | 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. |
| 25730283 | Background | 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. |
| 25083773 | Background | 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. |
| 30342026 | Background | 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. |
| 15605005 | Background | 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. |
| 22310222 | Background | 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. |
| 34362780 | Background | 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. |
| D013272 | Stomach Diseases |