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Completed

NCT Number: NCT04494919

Novel Stent Placement Technique for Intestinal Stenosis Assisted by an Ultrafine Endoscope

Colorectal cancer is the third most common cancer worldwide and results in 8-25% acute malignant bowel obstruction. Since Dohmoto et al. first applied and reported the self-expanding metal stents (SEMS) in the treatment of colorectal stenosis, they have been widely used not only as an alternative treatment as a bridge to surgery (BTS), but also as a mean of palliative option for stenosing lumen in clinical practice. Numerous publications have reported that the stent placement technique showed 75% to 100% technical success rates and 84% to 100% clinical success rates. However, it is sometimes difficult to place due to the distorted anatomy or acute angulations in patients and other conditions with poor endoscopic visualization with the normal colonoscope. The aims of this study were to present our results with two novel SEMS implantation techniques.

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Key information

Conditions

Colorectal Carcinoma Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ningbo first hospital

Ningbo, Zhejiang, 315000, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years old
  • Patients with colorectal cancer stenosis
  • Patients with intestinal stent implantation in digital subtraction angiography room

Exclusion criteria

  • Patients undergoing conventional intestinal stent implantation

Treatment and study plan

Ultrafine Endoscope

Device

The reversal of the normal colonoscope (CV-260SL; Olympus, Tokyo, Japan) along the guidewire to replace the UFE (GIF-XP260NS; Olympus, Tokyo, Japan).

Primary outcomes

  1. The technical success rate

    Time frame: 1 hour

    the ratio between the patients with correctly placed SEMS and those scheduled for SEMS implantation.

Secondary outcomes

  1. The clinical success rate

    Time frame: 24 hours

    the ratio between the patients with regressive signs and symptoms of obstruction (within 24 h) and those succeeded for SEMS implantation.

  2. The adverse events rate

    Time frame: 2 year

    the ratio between the patients with adverse events (like perforation, bleeding, and reobstruction) and those succeeded for SEMS implantation.

Sponsors and collaborators

Lead sponsor

Ningbo No. 1 Hospital

Other

Registry information

Official study title

Two Different Novel Stent Placement Technique for Intestinal Stenosis Assisted by an Ultrafine Endoscope

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 31, 2020
Registry last updated
Aug 4, 2020

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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