ClinicalTrials.gg
RecruitingNCT06097637Updated Dec 18, 2024

Underwater Endoscopic Mucosal Resection Versus Metal Clips With Hot Snare Polypectomy for Resection of Big Pedunculated Colorectal Polyps

An interventional study of underwater endoscopic mucosal resection and hot snare polypectomy in Pedunculated Colorectal Polyps and Haemorrhage, sponsored by Ningbo No. 1 Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-12-18.

Sponsored by Ningbo No. 1 Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2023; still recruiting 3 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
156
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Endoscopic resection of pedunculated polyps mainly focuses on how to prevent bleeding, and also needs to pay attention to the convenience of resection and the integrity of resection, which means that different endoscopic resection strategies should be adopted for pedunculated polyps with different pedicle sizes. The head larger than 20mm or pedicle larger than 5mm are defined as large pedunculated polyps, which are at greater risk of bleeding. Current guidelines recommend hot removal by snare following preoperative saline injection, ligation of the pedicle with a nylon ring or metal clip, depending on the size of the polyp head and pedicle. However, the use of snares and metal clamps does not appear to reduce delayed postoperative bleeding, and the technical requirements of nylon ligation are relatively high. Recent studies have found that Underwater endoscopic mucosal resection (UEMR) is also safe and effective for the treatment of large and medium colorectal sessile polyps. Therefore, it is still necessary to further explore new safe and effective endoscopic resection strategies and techniques.

02

Conditions studied

  • Pedunculated Colorectal Polyps
  • Haemorrhage

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03

In context

Hemorrhage

1,383 studies on the registry are indexed under Hemorrhage; 244 are open to participants now.

This study's planned enrollment of 156 is above the median of 102 across 926 interventional studies indexed under Hemorrhage.

Browse Hemorrhage studies →

Lead sponsor

Ningbo No. 1 Hospital is the lead sponsor of 59 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients undergoing endoscopic resection of small and medium pedicled polyps in the First Affiliated Hospital of Ningbo University from October 2023 to August 2026;
  2. Age 18-75 years old;
  3. Patients who voluntarily agreed to participate in this study and signed .

Exclusion criteria

Exclusion Criteria:

  1. Persons under 18 years of age
  2. Persons unwilling or unable to provide
  3. Treatment or radiotherapy for malignant diseases, severe chronic heart or lung diseases, coronary or cerebrovascular events requiring hospitalization within the last 3 months
  4. Malignant polyps have infiltrated the pedicle
  5. Abdominal symptoms such as severe abdominal pain, abdominal distension, and nausea
  6. Patients with inadequate intestinal preparation
  7. Patients with lifelong anticoagulant therapy or severe bleeding diseases, patients who have recently taken anticoagulant drugs or antiplatelet drugs (within 1 week)
  8. Pregnant or lactating
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
156 participants (estimated)

Study arms

  • Experimental
    underwater endoscopic mucosal resection

    underwater endoscopic mucosal resection for resection of big pedunculated colorectal polyps

    Other: underwater endoscopic mucosal resection

  • Active comparator
    hot snare polypectomy

    hot snare polypectomy for resection of big pedunculated colorectal polyps

    Other: hot snare polypectomy

Interventions

  • Otherunderwater endoscopic mucosal resection

    underwater endoscopic mucosal resection achieves similar rates of complete resection with comparable safety, with lower rates of recurrence and fewer repeat procedures.

  • Otherhot snare polypectomy

    Current guidelines recommend preoperative hot snare polypectomy after preoperative saline injection, nylon ring, or metal clip ligation of the tip and pedicle of the polyps

06

What researchers measure

Primary outcomes

  1. Prevalence of immediate bleeding

    Immediate bleeding was defined as an intraoperative bleeding immediately after Immediate bleeding staging: If there is no bleeding, fill in 'none'; Level 1, spontaneous hemostasis within 60 seconds; Level 2, continuous small bleeding for more than 60 seconds; Level 3, continuous bleeding for more than 60 seconds requires endoscopic treatment; Level 4, arterial spray

    Time frame: 1 Minutes

Secondary outcomes

  1. delayed hemorrhage

    Any symptoms of gastrointestinal bleeding (e. g. hematochezia) occurred within 30 days after polypectomy and were classified as mild or severe according on the severity of the bleeding

    Time frame: 2 weeks and 4 weeks

Other outcomes

  1. Immediate perforation rate

    perforation

    Time frame: 30 seconds

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2023 (actual). Primary completion is estimated for Aug 2026, 34 months after the start.

Of 191 non-industry interventional studies with no phase under Hemorrhage, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 37. This study's planned 34 months is above that.

Counting every sponsor, half of 226 studies reached it within 19 months; a quarter within 9 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 18, 2023
First posted
Oct 24, 2023
StartActual
Oct 19, 2023
Primary completionEst.
Aug 31, 2026
CompletionEst.
Aug 31, 2026
Last update
Dec 18, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06097637
Lead sponsor
Ningbo No. 1 Hospital
Responsible party
Sponsor
First posted
Oct 24, 2023
Start date
Oct 19, 2023
Primary completion
Aug 31, 2026 (estimated)
Completion
Aug 31, 2026 (estimated)
Last update
Dec 18, 2024

Study contacts

Lei Xu
Contact
xulei22@163.com
+8613486659126

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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