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NCT Number: NCT06973083

Efficacy and Safety of Robot-assisted Endoscopic Submucosal Dissection for Colorectal Neoplasm

The objective of this study is to investigate the role of the flexible auxiliary single-arm transluminal endoscopic robot (FASTER) system in colorectal endoscopic submucosal dissection (ESD) and to validate its superiority over conventional ESD in terms of reducing procedural difficulty, shortening procedure time, and enhancing procedural safety.

The main questions it aims to answer are:

Does the use of the FASTER system improve the dissection speed of the ESD procedure? Does the use of the FASTER system reduce the procedure and dissection time, improving the efficacy of the ESD procedure? Does the use of the FASTER system reduce the rate of perforation and hemorrhage, improving the safety of the ESD procedure? Researchers will compare FASTER-assisted ESD and conventional ESD to evaluate the safety and efficacy of the FASTER system.

Participants will:

Be randomly assigned to the group with ESD using the traditional procedure or to the group with ESD assisted by the FASTER system.

Keep a diary of their symptoms after the procedure. ESD has gained widespread acceptance as the standard method for treating early-stage gastrointestinal cancers. However, ESD is a technically demanding and intricate procedure that requires advanced proficiency of operators, with a heightened risk of complications such as hemorrhage and perforation. The inherent challenges of the colorectal ESD are further amplified by the thin mucosa, highly tortuous and flexible lumen, and occasional obstruction of lesions by mucosal folds, all of which collectively elevate both the procedural difficulty and the probability of postoperative complications. Adequate exposure of the submucosa layer through effective tissue traction is vital for the safe and effective performance of ESD. The FASTER system is designed to overcome this technical difficulty.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged 18-85.
  • Patients with pathologically verified colorectal neoplasms scheduled to undergo ESD.

Exclusion criteria

  • Patients have lesions with confirmed or potential deep submucosal invasion or lymph node metastasis or other conditions that are not suitable for endoscopic therapy.
  • Patients with severe underlying diseases precluding endotracheal intubation, general anesthesia, or surgery.
  • Patients have a history of colorectal malignancy with previous radiotherapy or operative treatment leading to changes in colorectal structure.
  • Patients have lesions with local recurrence after endoscopic resection.
  • Patients unable to obtain informed consent.

Treatment and study plan

FASTER-assisted ESD

Procedure

The patients who are randomly assigned to the FASTER-assisted ESD group will undergo the ESD procedure with the assistance of the FASTER system.

Conventional ESD

Procedure

The patients who are randomly assigned to the conventional ESD group will undergo the ESD following the clinically established pattern.

Primary outcomes

  1. procedure time

    Time frame: Within 24 hours after the procedure.

    Procedure time is the time from the beginning of injection to the completion of dissection.

Secondary outcomes

  1. dissection time

    Time frame: Within 24 hours after the procedure.

    Dissection time is the time from the beginning of dissection to the completion of dissection.

  2. dissection speed

    Time frame: Within 24 hours after the procedure.

    Dissection speed is defined as the lesion area divided by the dissection time.

  3. en bloc resection rate

    Time frame: Within 24 hours after the procedure.

    En bloc dissection refers to the complete removal of the entire lesion in a single piece.

  4. R0 resection rate

    Time frame: Within 24 hours after the procedure.

    R0 resection is defined as en bloc resection with negative vertical and horizontal margins.

  5. perforation rate

    Time frame: Within 24 hours after the procedure.

    Perforation were defined as: endoscopic visualization of mural transection during ESD, or postoperative clinical signs combined with radiologically confirmed pneumoperitoneum.

  6. postoperative hemorrhage rate

    Time frame: Within 24 hours after the procedure.

    Post-ESD hemorrhage was strictly defined as meeting ≥1 of: hematemesis or melena with dizziness, hemoglobin decline >20 g/L, SBP drop >20 mmHg or HR elevation >20 bpm, presence of bloody fluid in nasogastric tube drainage, or active bleeding confirmed by repeat endoscopy.

  7. intraoperative hemorrhage rate

    Time frame: Within 24 hours after the procedure.

  8. the proportion of intraoperative hemorrhage ≥ grade 2

    Time frame: Within 24 hours after the procedure.

    Intraoperative hemorrhage is divided into four grades: Grade 0 means no significant bleeding is observed during the procedure. Grade 1 means minimal bleeding, which could stop spontaneously or be easily controlled by cauterization with a dual knife. Grade 2 refers to minor hemorrhage that requires multiple cauterizations with a dual knife or hemostatic forceps. Grade 3 indicates massive hemorrhage that requires multiple cauterizations with hemostatic forceps.

  9. hemostasis time

    Time frame: Within 24 hours after the procedure.

    Hemostasis time referred to the time from the detection of submucosal bleeding until hemostasis was completed.

  10. muscular injury rate

    Time frame: Within 24 hours after the procedure.

    Muscular injury is described as visible damage to the muscularis propria.

  11. direct-vision dissection rate

    Time frame: Within 24 hours after the procedure.

    Direct-vision dissection time is the time that the endoscopist can directly observe the tip of the dual knife and the submucosal layer at the same time. By dividing the direct-vision dissection time by the total dissection duration, the direct-vision dissection rate is calculated.

  12. postoperative pain score

    Time frame: 3 days after the procedure.

    Postoperative pain score was assessed via the 11-point Numerical Rating Scale (NRS: 0=no pain, 10=worst imaginable pain). Patients independently rated their pain intensity on postoperative day 3, with scores categorized as mild (1-3), moderate (4-6), or severe (7-10).*

  13. the frequency of supplemental injections

    Time frame: Within 24 hours after the procedure.

    Supplemental injection refers to injections performed after the beginning of the dissection.

  14. the supplemental injections time

    Time frame: Within 24 hours after the procedure.

    The time of supplementary injection is from the insertion of the injection needle into the submucosal layer until the injection is completed and the needle is withdrawn.

  15. Volume of injection fluid used in supplemental injections

    Time frame: Within 24 hours after the procedure.

  16. the frequency of intraoperative patient positioning changes

    Time frame: Within 24 hours after the procedure.

  17. time required for patient positioning changes

    Time frame: Within 24 hours after the procedure.

  18. NASA-TLX scale scores

    Time frame: Within 24 hours after the procedure.

Study contacts

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

Xiuli Zuo, Professor, MD, PhD

CONTACT

[email protected]

86+18560080066

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Registry information

Official study title

Efficacy and Safety of Robot-assisted Endoscopic Submucosal Dissection for Colorectal Neoplasm: A Randomized Controlled Trial.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 15, 2025
Registry last updated
May 21, 2025

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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