Hemoclipping vs Standard Treatment for Upper GI Bleeding

Recruiting at 1 trial location

Overseen By Kwanmanus N Suvanamas, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: CURE Digestive Diseases Research Center

Disqualifiers: Active GI malignancy, Hypovolemic shock, Coagulopathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 week

65 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device designed to stop bleeding in the upper digestive system. It compares the over-the-scope hemoclipping method (using the Over-the-scope Hemoclipping Device) to standard treatments to determine which better prevents rebleeding within 30 days in individuals with severe bleeding from ulcers or specific lesions. Individuals with severe upper GI bleeding and a benign (non-cancerous) ulcer or specific lesions, such as Dieulafoy's, may be suitable candidates. The goal is to identify which treatment leads to better outcomes in managing this type of bleeding. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future treatment options.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more information.

What prior data suggests that the over-the-scope hemoclipping device is safe for treating upper GI bleeding?

Research shows that the over-the-scope hemoclipping device is generally safe for treating bleeding in the upper digestive system. Studies have found this device effective and easy to use for managing bleeding and other issues in the digestive tract. It works by using a clip to hold tissue together, stopping the bleeding.

A review of the device highlighted its safety and effectiveness for controlling bleeding in the digestive system. The FDA has approved the device, indicating it has passed safety checks for other uses.

Overall, patients have well-tolerated the hemoclipping device, with few side effects reported. However, as with any treatment, individual reactions can vary. Participants should discuss any concerns with their healthcare providers. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the over-the-scope hemoclipping device because it offers a novel approach to managing upper GI bleeding. Unlike standard treatments, which include methods like epinephrine injections and multipolar electrocautery, the hemoclipping device uses a mechanical method to directly compress and stop bleeding. This device is designed to provide immediate and effective hemostasis by capturing and sealing the bleeding area with a clip. This technique could potentially improve the speed and reliability of treatment compared to traditional methods, making it an exciting advancement in the field.

What evidence suggests that this trial's treatments could be effective for upper GI bleeding?

Research has shown that over-the-scope clips (OTSCs), one of the treatments studied in this trial, hold promise for treating upper gastrointestinal (GI) bleeding not related to varicose veins. Studies have found OTSCs to be generally more effective than standard endoscopic methods, which are also evaluated in this trial. One study demonstrated that OTSCs were better at stopping bleeding in patients with recurring peptic ulcer bleeding compared to regular treatments. Another research review found that OTSCs could control bleeding in cases where standard methods failed, which occurs in about 20% of patients. Overall, OTSCs seem to offer a more reliable solution for managing upper GI bleeding than traditional options. ^{1 2 4 6 7}

Who Is on the Research Team?

Dennis M Jensen, MD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for people with severe non-variceal upper GI bleeding, specifically from ulcers or Dieulafoy's lesions. Participants must be able to give consent, have a life expectancy of at least 30 days without severe terminal illness, and show signs of active bleeding on endoscopy.

Inclusion Criteria

I have a non-cancerous stomach or intestinal ulcer seen during an endoscopy.

I have severe upper gastrointestinal bleeding.

I have severe bleeding in my upper digestive system.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the over-the-scope hemoclipping device or standard endoscopic treatment for severe non-variceal UGI hemorrhage

1 week

1 visit (in-person)

Follow-up

Participants are monitored for rebleeding rates and other clinical outcomes

4 weeks

1 visit (in-person)

30-day Follow-up

Participants are assessed for rebleeding rates, surgery or IR, complications, and death

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Over-the-scope Hemoclipping Device
• Standard Endoscopic Treatment

Trial Overview The study compares two treatments for stopping severe upper GI bleeding: a new device called an over-the-scope-clip versus the standard treatment. Patients will be randomly assigned to one of these methods to see which is more effective at preventing rebleeding within 30 days.

How Is the Trial Designed?

Group I: Standard endoscopic treatment Experimental Treatment 1 Intervention

For those assigned to the standard endoscopy group, endoscopic hemostasis is performed using usual CURE hemostasis therapy for the focal GI lesions: injection of dilute (e.g. 1: 20,000) epinephrine (in 1-2 cc aliquots in 4 quadrants next to the SRH) of active bleeding or adherent clots (prior to snaring them off); coaptive coagulation with multipolar electrocautery (MPEC) probe and/or standard through the endoscope hemoclips along the course of the underlying artery as detected by DEP. Hemostasis is performed until active bleeding stops and/or the SRH is obliterated. Residual blood flow after visually guided hemostasis is recorded, but not used as a guide for additional hemostasis in this study.

Group II: Over-the-scope hemoclipping device Experimental Treatment 1 Intervention

For those assigned OTSC, prior to use of the OTSC in UGI lesions with active bleeding or adherent clots, dilute epinephrine (1: 20,000) is injected around the SRH in 1-2 cc aliquots and the clots are cold guillotined off, as previously described (2, 4, 17). As a brief additional description, after initial diagnosis and preparation of the lesion and SRH (as described for standard hemostasis), the therapeutic sized endoscope is removed and this or a diagnostic panendoscope will be affixed with the OTSC of appropriate size for the endoscope and the target lesion. The endoscope is re-introduced and passed to the bleeding site. The SRH is centered in the field of view and within the cap of the OTSC device. Using high suctioning and firm pressure to center the SRH, the lesion and SRH is captured into the cap and the OTSC is deployed by rotating the handle and thereby compressing the bleeding lesion and surrounding tissue with mechanical hemostasis.

Over-the-scope Hemoclipping Device is already approved in European Union, United States, China for the following indications:

Approved in European Union as OTSC for:

• Non-variceal upper gastrointestinal bleeding (NVUGIB)
• Perforations
• Fistulas

Approved in United States as OTSC for:

• Non-variceal upper gastrointestinal bleeding (NVUGIB)
• Perforations
• Fistulas

Approved in China as OTSC for:

• Non-variceal upper gastrointestinal bleeding (NVUGIB)
• Perforations
• Fistulas

Who Is Running the Clinical Trial?

CURE Digestive Diseases Research Center

Lead Sponsor

Trials

2

Recruited

90+

VA Greater Los Angeles Healthcare System

Collaborator

Trials

53

Recruited

8,700+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

Published Research Related to This Trial

The Over-The-Scope Clip (OTSC) is highly effective for treating gastrointestinal defects in acute settings, achieving a 100% technical success rate and a long-term clinical success rate of 100% in 15 patients.

In contrast, the OTSC showed lower effectiveness for chronic gastrointestinal defects, with only a 50% technical success rate and a long-term clinical success rate of 37% in 30 patients, indicating that while OTSC is a valuable tool for acute cases, its application in chronic situations may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Closure of gastrointestinal defects with Ovesco clip: long-term results and clinical implications. Donatelli, G., Cereatti, F., Dhumane, P., et al.[2020]

Over-the-scope clips (OTSC) are effective for closing bowel perforations and achieving hemostasis, but complications such as misplacement can occur, as demonstrated in a case of upper gastrointestinal bleeding.

In this case, the remOVE system was successfully used to remove a misplaced OTSC, highlighting the importance of having a reliable removal method for complications associated with OTSC use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute Pancreatitis Due to Clipping of the Ampulla With Over-The-Scope Clip as a Complication of Bleeding Duodenal Ulcer Treatment. Sehmbey, G., Srinivasan, I., Chuang, KY.[2020]

The over-the-scope clip (OTSC) system demonstrated a high clinical success rate of 78.4% across various gastrointestinal (GI) indications, with particularly high success rates for GI hemorrhage (86.0%) and defect closure after endoscopic resection (92.8%).

The OTSC system has a low adverse event rate of 2.1%, indicating it is a safe option for managing GI issues, although its effectiveness in treating fistulae is limited, suggesting the need for further research to optimize its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical efficacy of the over-the-scope clip device: A systematic review. Bartell, N., Bittner, K., Kaul, V., et al.[2021]

The over-the-scope clip (OTSC) achieved primary successful hemostasis in 92.4% of patients with non-variceal upper gastrointestinal bleeding (NVUGIB), demonstrating its efficacy as a first-line endoscopic treatment.

In high-risk patients (Rockall risk category ≥8), OTSC significantly reduced mortality after rebleeding from 27.9% to 10.9%, and also lowered rebleeding rates compared to standard care, indicating it may be the preferred treatment option for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter evaluation of first-line endoscopic treatment with the OTSC in acute non-variceal upper gastrointestinal bleeding and comparison with the Rockall cohort: the FLETRock study. Wedi, E., Fischer, A., Hochberger, J., et al.[2022]

The over-the-scope-clip (OTSC) system was found to be highly effective for managing acute non-variceal upper gastrointestinal bleeding, achieving a technical success rate of 95.7% across 16 studies involving 769 patients.

The OTSC system demonstrated a low complication rate of only 0.3%, indicating it is a safe option for patients, despite a post-procedure mortality rate of 10.9%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of over-the-scope-clip system for the treatment of acute upper non-variceal gastrointestinal bleeding: a systematic review and meta-analysis. Zhong, C., Tan, S., Ren, Y., et al.[2020]

In a study of 173 patients treated for duodenal ulcer bleeding using over-the-scope clips (OTSCs), the atraumatic type (OTSC-a) demonstrated significantly lower rates of recurrent bleeding compared to the traumatic type (OTSC-t), with rates of 7.6% versus 34.9%, respectively.

Both types of OTSCs showed similar initial hemostasis rates and 72-hour mortality, but the OTSC-a was associated with fewer red blood cell transfusions, suggesting it is the safer and more effective option for managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison between traumatic and atraumatic over-the-scope clips in patients with duodenal ulcer bleeding: a retrospective analysis with propensity score-based matching. Hollenbach, M., Decker, A., Schmidt, A., et al.[2023]

In a study of 30 patients with severe acute gastrointestinal bleeding unresponsive to standard treatments, the over-the-scope clip (OTSC) achieved primary hemostasis in 97% of cases, demonstrating its high efficacy.

The OTSC was found to be a safe option, with only two cases of rebleeding that were successfully managed with conventional methods, indicating its reliability in critical situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Over-the-scope clip (OTSC) represents an effective endoscopic treatment for acute GI bleeding after failure of conventional techniques. Manta, R., Galloro, G., Mangiavillano, B., et al.[2022]

In a multicenter trial involving 100 patients with large peptic ulcers, the over-the-scope clip (OTSC) achieved primary hemostasis in 92% of cases, similar to the 96% success rate of conventional therapy.

Despite a higher initial success in preventing rebleeding in the OTSC group (4.35% vs. 18.75%), the overall 30-day rebleeding rates were not significantly different between OTSC and standard treatment, indicating that OTSC may not provide a clear advantage in routine use for large bleeding peptic ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of over-the-scope clip (OTSC) versus standard therapy for the prevention of rebleeding in large peptic ulcers (size ≥1.5 cm): an open-labelled, multicentre international randomised controlled trial. Chan, S., Pittayanon, R., Wang, HP., et al.[2023]

The over-the-scope-clip (OTSC) achieved primary hemostasis in 94% of patients with non-variceal upper gastrointestinal bleeding (NVUGIB), demonstrating its effectiveness as a treatment option.

In a cohort of 100 patients, including many with severe cardiovascular comorbidities, OTSC showed a long-term success rate of 86% without rebleeding over a mean follow-up of 6 months, indicating its safety and reliability in high-risk cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the over-the-scope-clip (OTSC) in non-variceal upper gastrointestinal bleeding in patients with severe cardiovascular comorbidities: a retrospective study. Wedi, E., von Renteln, D., Gonzalez, S., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6929512/

Clinical outcomes of over-the-scope-clip system for ... Conventional endoscopic treatments can't control bleeding in as many as 20% of patients with non-variceal gastrointestinal (GI) bleeding.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7406817/

Outcomes of over-the-scope clip application in various ... We found that OTSC is safe and easy to use for GI defects and bleedings. In addition, the newly available OTSC was effective in securing esophageal metal ...

3. gi.org gi.org/journals-publications/ebgi/kolb_may2023/

Over-the-Scope Clips Decrease Non-Variceal Upper GI ... 5 RCTs assessing their efficacy for nonvariceal upper GI bleeding have generally demonstrated superiority of OTSCs to standard endoscopic intervention.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03065465

Standard Endoscopic Hemostasis Versus OVESCO Severe ... The primary specific aim is to perform a randomized controlled trial (RCT) to compare 30 day rebleed rates and other clinical outcomes of patients with ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0016508518345700

Over-the-Scope Clips Are More Effective Than Standard ... In this study, endoscopic hemostasis with OTSCs was superior to standard therapy in patients with recurrent peptic ulcer bleeding.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03216395

Study Details | NCT03216395 | Over-the-scope Clips and ... The Over-the-scope-Clip (OTSC) is a device, which allows endoscopists to capture a large amount of tissue and compress on the bleeding artery.

7. ovesco.com ovesco.com/wp-content/uploads/media/PDFs/OVE_OTSCHemostasisUpdate.pdf

OTSC® Hemostasis Update 13 | Research & clinical trials 1 The authors concluded that this systematic review confirms the safety and efficacy of the OTSC System in the management of GI hemorrhage, perforations,.