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NCT Number: NCT06748352

Safety and Efficacy of Traction Robot-assisted Endoscopic Submucosal Dissection for Early Gastric Cancer

The goal of this clinical trial is to investigate whether the flexible auxiliary single-arm transluminal endoscopic robot (FASTER) system can improve the safety of the endoscopic submucosal dissection (ESD). It will also evaluate the efficacy of the system, such as whether it could reduce the procedure time and so on. The main questions it aims to answer are:

Does the use of the FASTER system reduce the number of muscular injuries, improving the safety of the ESD procedure? Does the use of the FASTER system reduce the procedure and dissection time, improving the efficacy 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. 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

Conditions

Early Gastric Cancer Digestive System Diseases Digestive System Neoplasms Endoscopic Submucosal Dissection Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Robot Surgery Stomach Diseases Stomach Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location status: Recruiting

Location contact

Xiuli Zuo Professor, MD, PhD

CONTACT

[email protected]

+86 18560080066

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged 18-80.
  • Patients with pathologically verified high-grade intraepithelial neoplasia (HGIN) or intramucosal carcinoma of the stomach.

Exclusion criteria

  • Patients have lesions with confirmed or potential deep submucosal invasion or lymph node metastasis.
  • Patients with severe underlying diseases precluding endotracheal intubation, general anesthesia, or surgery.
  • Patients have a history of gastric malignancy with previous radiotherapy or operative treatment leading to changes in gastric 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. the number of muscular injuries

    Time frame: Within 24 hours after the procedure.

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

Secondary outcomes

  1. the incidence of muscular injury

    Time frame: Within 24 hours after the procedure.

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

  2. the frequency of intraoperative hemorrhage

    Time frame: Within 24 hours after the procedure.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

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

Safety and Efficacy of Traction Robot-assisted Endoscopic Submucosal Dissection for Early Gastric Cancer: a Pilot Randomized Controlled Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 27, 2024
Registry last updated
Dec 27, 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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