The UGIRA International Registry for RAMIG for Gastric Cancer

NCT07517432 | Recruiting DMC

• 1 other identifier: 2021.043
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Minimally invasive gastrectomy (MIG) has gained in popularity, since it is feasible, safe and oncologically comparable to open gastrectomy, while morbidity and duration of hospitalization are reduced, quality of life is increased, and conversion rate is low. However, several challenges are faced during MIG, such as impaired depth perception and limited range of motion of instrument tips. Robot-Assisted Minimally Invasive Gastrectomy (RAMIG) can potentially overcome these challenges, while providing comparable results regarding safety, technical feasibility, morbidity and oncological effectiveness. However, the techniques and outcomes of RAMIG vary in literature, which can partly be explained by lack of uniform definitions of postoperative outcomes that would allow international comparison. Furthermore, RAMIG is technically demanding and therefore associated with a learning curve. To facilitate safe and effective implementation of RAMIG worldwide, the learning curve for RAMIG-procedures must be evaluated in detail. A prospective international registry with uniform data collection regarding surgical techniques and postoperative outcomes can provide a platform for multicontinental studies and the monitoring of surgical quality for surgeons who are implementing RAMIG in their center. Therefore, the aim of this study proposal is to expand the Upper Gastrointestinal International Robotic Association (UGIRA) collaboration by creating the UGIRA International Registry for RAMIG. The UGIRA network extends worldwide with members in Europe, Asia, North-America and South-America, therefore representing large-scale practice of RAMIG. The initial specific aims of the registry are to gain insight in surgical techniques and postoperative outcomes of RAMIG worldwide, and to evaluate the learning curve for RAMIG. Data for this registry is collected prospectively and retrospectively.

Conditions

Gastric Cancer (Diagnosis); Gastrectomy

Keywords

gastric cancer; Gastrectomy

Outcome Measures

Primary Outcomes (6)

• Operation Outcome - operating time

  Operating time (minutes)

  During the entire length of the operation

• Operation Outcome - intraoperative blood loss

  intraoperative blood loss (milliliters)

  During the entire length of the operation

• Operation Outcome - intraoperative complications

  intraoperative complications (percentage)

  During the entire length of the operation

• Operation Outcome - conversion rate

  conversion rate (percentage)

  During the entire length of the operation

• Operation Outcome - completeness of resection

  completeness of resection (percentage)

  During the entire length of the operation

• Operation Outcome - lymph node yield

  lymph node yield (number)

  During the entire length of the operation

Secondary Outcomes (1)

• Adverse Event and Serious Adverse Event

  within 30 and 90 days after surgery

Study Arms (1)

All patients undergoing Robot-Assisted Minimally Invasive Gastrectomy.

All patients with gastric cancer, who is about to undergo Robot-Assisted Minimally Invasive Gastrectomy.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All gastric cancer patients undergoing RAMIG in a center

You may qualify if:

• All gastric cancer patients undergoing RAMIG in a center

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong, Shatin, HK

Hong Kong, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Histopathological data of the resection specimen: tumor histology, pathological stage of disease (pTNM, version 8 of the AJCC staging system), total number of lymph nodes retrieved, number of tumor positive lymph nodes, radicality (R0, R1, or R2), histopathologic response to neoadjuvant therapy (Mandard score23).

MeSH Terms

Conditions

Stomach Neoplasms; Disease

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shannon Melissa CHAN, MBChB, FRCSEd, FHKAM (Surgery)

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shannon Melissa CHAN, MBChB, FRCSEd, FHKAM (Surgery)

CONTACT

+852 3505 2956; shannonchan@surgery.cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: April 8, 2026
• Study Start: April 1, 2021
• Primary Completion (Estimated): March 31, 2031
• Study Completion (Estimated): March 31, 2031
• Last Updated: April 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)