Gastroduodenal UlcerNCT06393907

Hemostatic Forceps vs. Bipolar Electrocautery Probes for High-Risk Bleeding Gastroduodenal Ulcers

A study testing Hemostatic Forceps and Bipolar Electrocautery Probes in people with Gastroduodenal Ulcer, run by Mahidol University at 1 site in Thailand.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

A randomized controlled trial to evaluate the efficacy of hemostatic forceps and bipolar electrocautery probes in patient with high risk bleeding gastroduodenal ulcers. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Gastroduodenal Ulcer
What is being tested?: Hemostatic Forceps and Bipolar Electrocautery Probes
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 1 siteThailand
Study dates: 26 Mar 2024to 26 Apr 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The patient with upper gastrointestinal hemorrhage age ≥ 18 years old
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

Who cannot join

Uncorrectable hemostasis laboratory including serum platelet < 50000 /mm3 or International Normalized Ratio (INR) >1.5
Bleeding from cancerous gastroduodenal ulcer
The patient with history of gastric surgery
The patient with history of bleeding gastroduodenal ulcer within 30 days prior to enrollment
The patient with history of proton pump inhibitor allergy
Pregnant
The patient deny to participate in the study

Trial locations and contacts

1 site in 1 country.

Uayporn Kaosombattwattana, MD contact

+66619245953

Koigi214@gmail.com

Thailand1 site, 1 recruiting

Faculty of internal medicine siriraj hospital, Mahidol university
Bangkok Noi, Bangkok, 10700
Uayporn Kaosombatwattana, +66619245953, Koigi214@gmail.com
Recruiting

Other trials in Thailand

About this study

Official title: A Randomized Trial of Hemostatic Forceps Versus Bipolar Electrocautery Probes for High-Risk Bleeding Gastroduodenal Ulcers

A randomized controlled trial to evaluate the efficacy of hemostatic forceps and bipolar electrocautery probes in patient with high risk bleeding gastroduodenal ulcers.

Read the detailed description

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.

Conditions: Gastroduodenal Ulcer
Being tested: Hemostatic Forceps, Bipolar Electrocautery Probes
Keywords: Hemostatic Forceps, Bipolar Electrocautery Probes, Gastroduodenal Ulcer, Rebleeding, Hemostasis, Peptic ulcer
Medical subject headings: Peptic Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hemostatic ForcepsDevice
Also called Coagrasper (Olympus, Tokyo, Japan)
The experimental device will be used for control bleeding in high risk gastroduodenal ulcers.
Bipolar Electrocautery ProbesDevice
Also called Gold probe (Boston Scientific, Massachusetts, USA)
The active comparator devices will be used for control bleeding in high risk gastroduodenal ulcers.

Study groups in NCT06393907
Study group	Role	What they receive
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. Receives: Device: Hemostatic Forceps
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. Receives: Device: Bipolar Electrocautery Probes

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: During esophagogastroduodenoscopy

Secondary outcomes (6)

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.
Measured: 30 days
Survival rate after intervention
Patients who live longer than 30 days after hemostasis will be counted for survival rate.
Measured: 30 days
Procedure time for achieving hemostasis
Procedure time will be counted from the time of device insertion to the time of achieving hemostasis.
Measured: During esophagogastroduodenoscopy
Number of units of infused blood
Number of red cell units which are transfused to the patients.
Measured: 30 days
Duration of hospitalization
The length of hospital stay.
Measured: 30 days
Complications of hemostatic interventions
Complications related to intervention include perforation, infection, and organ failure
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Mar 202426 Apr 2026

First posted1 May 2024
Study start26 Mar 2024
Primary completion26 Mar 2026 (estimated)
Study completion26 Apr 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Gastroduodenal UlcerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Hemostatic Forceps versus Bipolar Electrocautery Probes
Masking: Single blind
Who is masked: Participant
Enrolment: 150 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06393907
Sponsor's protocol ID: Si 223/2024
Status last verified: Apr 2024
First submitted: 28 Apr 2024
Last updated: 1 May 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

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.
PubMed 21990954
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.
PubMed 4136718
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.
PubMed 31334417
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.
PubMed 19410037
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.
PubMed 20033825
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.
PubMed 25730283
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.
PubMed 25083773
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.
PubMed 30342026
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.
PubMed 15605005
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.
PubMed 22310222
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.
PubMed 34362780

Want to know more?

Uayporn Kaosombattwattana, MD

+66619245953

Koigi214@gmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Gastroduodenal Ulcer trials

Study at a glance

From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Trial of Hemostatic Forceps Versus Bipolar Electrocautery Probes for High-Risk Bleeding Gastroduodenal Ulcers
ClinicalTrials.gov ID: NCT06393907
Acronym / sponsor ID: Si 223/2024
Conditions: Gastroduodenal Ulcer
Keywords: Hemostatic Forceps, Bipolar Electrocautery Probes, Gastroduodenal Ulcer, Rebleeding, Hemostasis, Peptic ulcer
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 150 participants (estimated)
Lead sponsor: Mahidol UniversityUniversity, hospital or other
Study start: 26 Mar 2024 (actual)
Primary completion: 26 Mar 2026 (estimated)
Study completion: 26 Apr 2026 (estimated)
First posted: 1 May 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A randomized controlled trial to evaluate the efficacy of hemostatic forceps and bipolar electrocautery probes in patient with high risk bleeding gastroduodenal ulcers.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Hemostatic Forceps versus Bipolar Electrocautery Probes

Arm	Type	Receives
Hemostatic forceps	Experimental	Device: Hemostatic ForcepsHemostatic 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	Device: Bipolar Electrocautery ProbesBipolar electrocautery probes will be used for control bleeding with electrocautery unit setting: effect 2, soft coagulation bipolar mode for 8-10 seconds.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

The patient with upper gastrointestinal hemorrhage age ≥ 18 years old
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

Key exclusion criteria (7 listed)

Uncorrectable hemostasis laboratory including serum platelet < 50000 /mm3 or International Normalized Ratio (INR) >1.5
Bleeding from cancerous gastroduodenal ulcer
The patient with history of gastric surgery
The patient with history of bleeding gastroduodenal ulcer within 30 days prior to enrollment
The patient with history of proton pump inhibitor allergy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hemostatic ForcepsAlso: Coagrasper (Olympus, Tokyo, Japan)The experimental device will be used for control bleeding in high risk gastroduodenal ulcers.	Device	Hemostatic forceps
Bipolar Electrocautery ProbesAlso: Gold probe (Boston Scientific, Massachusetts, USA)The active comparator devices will be used for control bleeding in high risk gastroduodenal ulcers.	Device	Bipolar electrocautery probes

Primary outcome

Comparing hemostatic rate between hemostatic forceps and bipolar electrocautery probes
Time frame: During esophagogastroduodenoscopy
When the bleeding stopped for at least 2 minutes, it is defined as successful hemostasis.

6 secondary outcomes

Rebleeding rate at 7 days and 30 days after index intervention
Time frame: 30 days
Survival rate after intervention
Time frame: 30 days
Procedure time for achieving hemostasis
Time frame: During esophagogastroduodenoscopy
Number of units of infused blood
Time frame: 30 days
Duration of hospitalization
Time frame: 30 days
Complications of hemostatic interventions
Time frame: 30 days

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
Background: PubMed 21990954Charatcharoenwitthaya 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.
Background: PubMed 4136718Forrest 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.
Background: PubMed 31334417ASGE 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.
Background: PubMed 19410037Asge 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.
Background: PubMed 20033825Arima 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.
Background: PubMed 25730283Kim 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.
Background: PubMed 25083773Nunoue 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.
Background: PubMed 30342026Toka 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.
Background: PubMed 15605005Bianco 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.
Background: PubMed 22310222Laine 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.
Background: PubMed 34362780Veitch 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.

Related trials for Gastroduodenal Ulcer

Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
RecruitingObservational study
Efficacy and Safety of Esomeprazole 40 mg IV in Post-Surgical Patients Admitted to the ICU
Stress Ulcers, Reflux Episodes
Not yet recruitingPhase 4
PPI Dosing Per CYP2C19 Genotype
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Uayporn Kaosombattwattana, MD contact

+66619245953

Koigi214@gmail.com

Uayporn Kaosombatwattana, MD principal investigator

Mahidol University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Hemostatic Forceps and Bipolar Electrocautery Probes in people with Gastroduodenal Ulcer, run by Mahidol University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Uayporn Kaosombattwattana, MD (+66619245953, Koigi214@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparing hemostatic rate between hemostatic forceps and bipolar electrocautery probes (time frame: During esophagogastroduodenoscopy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06393907, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.