Hemoclipping vs Standard Treatment for Upper GI Bleeding

Recruiting at1 trial location

Overseen by Dennis M Jensen, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: CURE Digestive Diseases Research Center

No Placebo Group

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing a new medical device that clips onto bleeding areas in the stomach to stop bleeding more effectively. It targets patients with severe stomach bleeding who often experience rebleeding after standard treatments. The device works by grabbing larger areas of tissue and blood vessels to reduce rebleeding. The new clip overcomes limitations of standard clips and achieves a more efficient and reliable stopping of bleeding in the upper gastrointestinal tract.

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 data supports the idea that Hemoclipping vs Standard Treatment for Upper GI Bleeding is an effective treatment?

The available research shows that Hemoclipping, specifically using the over-the-scope clip (OTSC), is effective for treating upper GI bleeding. One study found that OTSC can control bleeding in cases where standard treatments fail, which happens in about 20% of patients. Another study showed that OTSC is better at stopping bleeding in large peptic ulcers compared to standard treatments. Overall, these studies suggest that Hemoclipping is a reliable option for managing difficult cases of upper GI bleeding. ^{1 2 3 4 5}

What safety data exists for Hemoclipping vs Standard Treatment for Upper GI Bleeding?

The Over-the-Scope Clip (OTSC) system is generally effective for managing acute GI bleeding, especially when conventional treatments fail. However, complications such as local inflammation, ulcers, or obstruction can occur, and misplacement of the clip may require removal. Systematic reviews suggest OTSC is effective for refractory bleeding, but safety data is limited and further evaluation is needed. ^{1 2 6 7 8}

Is the treatment Over-the-scope Hemoclipping Device a promising treatment for Upper GI Bleeding?

Yes, the Over-the-scope Hemoclipping Device is a promising treatment for Upper GI Bleeding. It has been shown to be more effective than standard treatments in stopping bleeding, especially in difficult cases where other methods fail. It can handle larger bleeding areas and provides reliable results, making it a valuable option for treating severe GI bleeding. ^{1 2 3 4 9}

Research Team

Dennis M Jensen, MD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

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.

Treatment Details

Interventions

• Over-the-scope Hemoclipping Device (Hemostasis Device)
• Standard Endoscopic Treatment (Procedure)

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.

Participant Groups

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 China for the following indications:

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+

Dr. Thomas Rando

University of California, Los Angeles

Chief Medical Officer since 2023

MD from UCLA

Amir Naiberg

University of California, Los Angeles

Chief Executive Officer since 2024

JD from UCLA

Findings from Research

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]

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 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]

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]

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]

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) 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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Over-the-scope clip (OTSC) represents an effective endoscopic treatment for acute GI bleeding after failure of conventional techniques. [2022]

2. England 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. [2020]

3. England 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. [2023]

4. United States 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. [2023]

5. Germany 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. [2022]

6. United States 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. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Clinical efficacy of the over-the-scope clip device: A systematic review. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Closure of gastrointestinal defects with Ovesco clip: long-term results and clinical implications. [2020]

9. Germany 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. [2022]