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NCT Number: NCT06726798

Prospective Cohort Study on the Safety and Efficacy of Endorobotics for Endoscopic Submucosal Dissection (Endorobotics ESD)

This trial is a prospective, single arm study of 30 patients recruited to undergo endoscopic submucosal dissection (ESD) with a novel robotic assisted technology. It will assess the safety and performance of robotic-assisted endoscopic submucosal dissection (ESD) of superficial gastric and colorectal lesions that otherwise cannot be optimally and radically removed by snare-based techniques. The primary outcome of the study is rate of complete (R0) resection of the neoplasia.

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Key information

Conditions

Gastrointestinal Neoplasm Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site

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 with endoscopic diagnosis of early gastric or colorectal neoplasia
  • Patients will be recruited according to ESGE and JGES guidelines for gastric & colorectal ESD including: 1. Lesions for which en bloc resection with snare EMR is difficult to apply; 2. Mucosal tumors with submucosal fibrosis; 3. Sporadic tumors in conditions of chronic inflammation and 4. Local residual or recurrent early carcinomas after endoscopic resection.

Exclusion criteria

  • Informed consent not available
  • Carcinoma of colon or rectum or stomach with invasion to submucosa or beyond
  • Evidence of distant metastasis
  • Presence of another active malignancy
  • Pregnancy
  • Patients unfit for general anesthesia
  • Endoscopic platform cannot reach target lesion
  • Patients recruited into another clinical trial.

Treatment and study plan

Endoscopic submucosal dissection with EndoRobotics traction device

Procedure

All patients received robotic ESD under general anesthesia or monitored anaesthetic care at the endoscopy center of Prince of Wales Hospital. The targeted lesion would first be localized and pre-injected using a mixture of normal saline, indigocarmine, epinephrine and sodium hyaluronate. The robotic endoscopic traction device was then inserted to reach the target. Mucosal incision first started from the anal side followed by lifting with the grasper[Figure 1; Video 1]. Vio 3 diathermy system (ERBE, Germany) was used with endocut Q effect 3 and forced coagulation effect 3. Further submucosal dissection would be performed by electrocautery knife with traction achieved via EndoRobotics traction. Upon completion, the specimen would be retrieved upon withdrawal of the whole system.

Primary outcomes

  1. R0 resection rate

    Time frame: 30 days

    Rate of complete en bloc, one-piece resection with histologically-confirmed tumour-free lateral and vertical margins

Secondary outcomes

  1. Rate of procedural haemorrhage

    Time frame: 30 days

    Hemorrhage at the resection site that requires transfusion, discontinuation of the procedure, or adjunctive open surgical control of haemorrhage, subcategorized by: Bleeding during the index procedure, or bleeding that occurs after the subject has left the procedure room after the index procedure.

  2. Rate of adjunctive procedure requirement

    Time frame: 30 days

    Need of adjunctive procedures, during study procedure required to control bleeding (e.g. clips or haemostatic agents)

  3. All cause mortality rate

    Time frame: up to 5 years

    Mortality rate after procedure

  4. Rate of infection

    Time frame: up to 12 months

    Clinical sepsis with changes in inflammatory markers (WCC, CRP, temperature)

  5. Duration of procedure

    Time frame: 1 day

    Total time of ESD procedure

  6. Length of hospital stay

    Time frame: 3 months

    Length of hospital stay (in days)

Study contacts

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

Philip Wai Yan Chiu, MBChB, FRCSEd, FHKAM, MD

CONTACT

[email protected]

+852 35052627

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 10, 2024
Registry last updated
Dec 10, 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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