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NCT Number: NCT06658561

Efficacy and Safety Research of Cold Snare Polypectomy and Hot Snare Polypectomy in the Treatment of 4-9 mm Diameter Colorectal 0-Isp and 0-Ip Polyps: a Prospective, Multicenter, Randomized Controlled Study(FAST -REST Study)

This study will evaluate the efficacy and safety of cold snare polypectomy(CSP) and hot snare polypectomy(HSP) in the treatment of colorectal 4-9mm 0-Isp and 0-Ip polyps, and compare the complete resection rate, postoperative late bleeding rate, intraoperative bleeding rate, en bloc resection rate, operation time and the number of metal clips used. The conclusion of this study will help clinical doctor develop more effective resection strategies for colorectal 0-Isp and 0-Ip polyps, and provide more effective treatment for patients.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Gastroenterolog, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location contact

Taojing Ran, MD

CONTACT

[email protected]

8615601942397

About this study

Colorectal polyps are one of the precancerous lesions of colorectal cancer, 60-80% of which eventually become advanced colorectal cancer. Therefore, early resection of colorectal polyps can effectively reduce the incidence of colorectal cancer. Polyps under white light are judged mainly according to the shape, size and color of polyps. At present, the Paris classification is often used to divide 0-I uplifted polyps into sessile polyps (0-Is), sessile-pedunculated polyps (0-Isp) and pedunculated polyps (0-Ip). It is generally believed that there are thick arteries in 0-Ip polyps, especially thick pedunculated polyps, which are prone to uncontrollable bleeding during operation. 0-Is polyps have small scattered blood vessels and low intraoperative bleeding risk, while the morphological and structural characteristics of 0-Isp polyps are between the two. The current guidelines recommend HSP for 0-Isp and 0-Ip polyps <1 cm, but the internal blood vessels of these polyps are not thick. There is no guidance on whether they can be resected by CSP method, and there is a lack of prospective large sample clinical research. This study will include0-Isp /0-Ip polyps <1cm, and observe the safety and effectiveness of CSP for the above polyp resection , so as to provide reference for the clinical treatment of colorectal polyps.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 18-80 years old, male or female
  • At least one polyp with size of 4-9 mm 0-Isp or 0-Ip is found during colonoscopy
  • Voluntarily sign informed consent for endoscopic treatment

Exclusion criteria

  • Boston Bowel Preparation Scale<6 points.
  • Patients who receive antiplatelet/anticoagulant therapy within 5 days before polypectomy.
  • Participants with a contraindication to colonoscopy and polypectomy.
  • Patients with inflammatory bowel disease or gastrointestinal polyposis.
  • Lesions with submucosal invasion and those suspected of being cancerous at the preprocedural diagnostic evaluation.
  • Patients with pregnancy.

Treatment and study plan

Cold snare polypectomy

Procedure

Place the special cold snare in the normal mucosa 1-2mm away from the polyp edge. Tighten the snare at a constant speed and gently lift it up and then excision.

Other names: CSP

hot snare polypectomy

Procedure

According to evaluation of the polyps, directly place the snare on the edge of the polyp including a clear margin of normal tissue (1-2 mm) or after submucosal injection. Tighten the snare at a constant speed and gently lift it up.Use the electrocoagulation and electroscission mode, power on for several seconds until the polyp is cut off.

Other names: HSP

Primary outcomes

  1. Complete resection rate

    Time frame: Up to 5-7 days from operation day

    The polyps and the two biopsies from the margin will be sent to the pathologist for further analysis. Two independent experienced pathologists will evaluate the samples separately and both are blinded to the technique performed for polypectomy. Complete resection rate is defined as the negative pathological evaluation of two biopsies obtained from the margin.

Secondary outcomes

  1. Postoperative delayed bleeding rate

    Time frame: Up to 14 days from operation day

    Incidence of bleeding requiring endoscopic hemostasis intervention within 14 days after surgery

  2. Intraoperative bleeding rate

    Time frame: Up to 1 minute from the time the polyp is resected

    Immediate bleeding is defined as bleeding persists >60s after polypectomy according to the ESGE recommendations (2017) and requires for endoscopic intervention.

  3. En bloc resection rate

    Time frame: Up to 7 days when the pathologists finish the evaluations.

    The lesion is removed at one time, and the integrity of the specimen is maintained

  4. Operation time

    Time frame: From the snare/ injection needle exits the working channel to leaving the wound.

    CSP: the time from the time the snare exits the working channel to leaving the wound. Hsp: time from the injection needle leaving the working channel to leaving the wound

  5. Other related postoperative complications

    Time frame: Up to 48 Hours from the time the polyp is resected

    Perforation, infection, electrocoagulation syndrome, etc

  6. Number of metal clips used

    Time frame: The time when the operation is completed

    Whether metal clips are used for hemostasis, and the number of metal clips

Study contacts

Contact information is provided by the study sponsor or research team.

Taojing Ran, MD

CONTACT

[email protected]

8615601942397

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Collaborators

  • Huadong Hospital
  • Jinshan Hospital Fudan University
  • People's Hospital Mojiang
  • Second Affiliated Hospital of Soochow University
  • Shanghai Yueyang Integrated Medicine Hospital
  • The Third People's Hospital of Yunnan Province

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 26, 2024
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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