AzTrials
AzTrials

Gastric CancerMSGNCT07899697

Feasibility Study of Middle Segmental Gastrectomy (MSG) for Gastric Cancer.

A study testing Totally Laparoscopic Middle Segmental Gastrectomy (TLMSG) in people with Gastric Cancer and Gastric Adenocarcinoma, run by National Cancer Center, Korea at 1 site in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This multicenter, prospective, single-arm phase 2 clinical trial aims to evaluate the safety, feasibility, and clinical applicability of Middle Segmental Gastrectomy (MSG) for patients with gastric cancer MSG is a function-preserving surgical technique that resects the middle portion of the stomach while preserving… Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Totally Laparoscopic Middle Segmental Gastrectomy (TLMSG)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteSouth Korea
Study dates
15 Jun 2025to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ① Diagnosed with gastric adenocarcinoma by tissue biopsy and capable of middle segmental gastrectomy by meeting the following oncologic characteristics on preoperative examination
  • The tumor is located in the mid body or high body
  • The tumor is 4 cm or less in size as described in endoscopy
  • cT1N0 or cT1N1, any differentiation
  • -cT2N0 or T2N1, well-differentiated or moderately-differentiated adenocarcinoma
  • Adult patients age 20 and older ③ ECOG performance is between 0 and 2
  • ASA score class I - III
  • Signed written informed consent, approved by the institutional review board, to participate in this study freely and voluntarily, after being fully informed of the purpose, content, and risks of the study prior to participation.

Who cannot join

  • Borrmann type 4 stomach cancer
  • Multiple gastric cancers or comorbid malignancies
  • Boundaries of the lesion are unclear
  • Clear mesenteric infiltration (T4) was determined at surgery. ⑤ Two or more lymph node infiltrates are visually connected at the time of surgery.
  • ⑥ Patients with other malignancies that affect gastric function preservation metrics
  • A history of cancer in other organs
  • Cancer in other organs
  • Patients with A history of gastrectomy surgery ⑦ Vulnerable populations (incapacitated, pregnant, or planning to become pregnant) ⑧ Other patients deemed difficult to study

Trial locations and contacts

1 site in 1 country.

South Korea1 site
  • National Cancer Center, Korea

    Goyang, Gyeonggido, 10408

Other trials in South Korea

About this study

Official title: A Multicenter, Prospective, Single-arm Clinical Trial on the Feasibility of Middle Segmental Gastrectomy (MSG)

This multicenter, prospective, single-arm phase 2 clinical trial aims to evaluate the safety, feasibility, and clinical applicability of Middle Segmental Gastrectomy (MSG) for patients with gastric cancer

  • MSG is a function-preserving surgical technique that resects the middle portion of the stomach while preserving the pylorus and the upper stomach (cardia and fundus) to minimize common postoperative issues such as dumping syndrome and nutritional deficiencies
Read more

The primary objective of the study is to determine the incidence of dumping syndrome at 1 year postoperatively (defined as a Sigstad score ≥ 7) and evaluate if it differs significantly from the 15.8% incidence reported for standard laparoscopic distal gastrectomy (LDG) in the KLASS 04 study . The study targets adult patients with mid- or high-body gastric adenocarcinoma with a tumor size of 4 cm or less at clinical stages cT1N0/1M0 or cT2N0/1M0 (well or moderately differentiated)

. Secondary evaluations include monitoring postoperative reflux symptoms, changes in nutritional indicators (such as weight and hemoglobin), quality of life (QOL) using EORTC QLQ-C30 and STO22, and 3-year recurrence-free and overall survival rates.

Read the detailed description

Standard surgical treatments for middle-body (MB) and high-body (HB) gastric cancer, such as distal gastrectomy (DG) or total gastrectomy (TG), are often associated with postgastrectomy syndrome, which significantly impacts a patient's quality of life

  • Middle Segmental Gastrectomy (MSG) is a function-preserving surgical alternative that resects only the middle portion of the stomach while preserving the pylorus and the upper stomach (cardia and fundus)
  • By maintaining these structures, MSG aims to preserve digestive function and minimize common postoperative issues like dumping syndrome and nutritional deficiencies

Preliminary cohort research indicates that MSG is oncologically safe for gastric adenocarcinoma tumors 4 cm or smaller in clinical stages cT1N0/1M0 (regardless of differentiation) and cT2N0/1M0 (well or moderately differentiated)

. This multicenter, prospective, single-arm phase 2 trial is designed to validate the safety, clinical applicability, and functional benefits of this technique in a prospective setting

. Surgical Intervention: Participants will undergo Totally Laparoscopic Middle Segmental Gastrectomy (TLMSG)

. The standardized surgical procedure includes: Resection: Removal of the middle segment with a minimum 2-3 cm resection margin from the tumor

. Vascular Preservation: Preservation of the vascular branches along the lesser and greater curvatures, specifically the right and left gastroepiploic arteries

. Lymph Node (LN) Dissection: Dissection of LN stations Nos. 1, 3, 4sb, 4d, 7, 8a, and 9, while omitting stations Nos. 5 and 6

. Reconstruction: A modified delta-shaped anastomosis using a straight automated anastomosis machine under laparoscopy

. Outcome Evaluation: The primary objective is to evaluate the incidence of dumping syndrome at 1 year postoperatively, defined as a Sigstad score of 7 or higher

. The study utilizes a one-sample proportion test to determine if the MSG group demonstrates a significantly different incidence rate compared to the 15.8% incidence reported for the laparoscopic distal gastrectomy (LDG) group in the KLASS 04 study

. Secondary objectives include the comprehensive assessment of

: Postoperative reflux symptoms: Monitored via subjective Visick scores and endoscopic LA classification.

Nutritional status: Long-term changes (up to 36 months) in weight, hemoglobin, vitamin B12, serum iron, albumin, and total protein.

Safety: Monitoring of early and late postoperative complications (Clavien-Dindo Classification) and 30-day mortality.

Quality of Life (QOL): Evaluated at 3, 12, 24, and 36 months using EORTC QLQ-C30 and STO22 questionnaires.

Oncologic Outcomes: Estimation of 3-year recurrence-free survival (DFS) and overall survival (OS) using the Kaplan-Meier method.

The study aims to enroll 78 subjects across multiple centers, with a recruitment period of 24 months and a total study duration of 72 months

Being tested
Totally Laparoscopic Middle Segmental Gastrectomy (TLMSG)
Keywords
Gastric Adenocarcinoma, Middle Segmental Gastrectomy (MSG), Function-preserving Gastrectomy, Modified Delta-shaped Anastomosis, Dumping Syndrome, Sigstad Score, Quality of Life (QOL), Multicenter Study, Feasibility Study
Medical subject headings
Stomach Neoplasms, Dumping Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Totally Laparoscopic Middle Segmental Gastrectomy (TLMSG)Procedure or surgery

    This is a function-preserving surgery that involves resecting the middle portion of the stomach while preserving the pylorus and the upper stomach (cardia and fundus) . The middle segment is resected with a minimum 2-3 cm margin from the tumor

    . Specific vascular branches are preserved, including the right and left gastroepiploic arteries

    . The lymph node dissection includes stations Nos. 1, 3, 4sb, 4d, 7, 8a, and 9, while omitting stations Nos. 5 and 6

    . Reconstruction is performed using a modified delta-shaped anastomosis with a straight automated anastomosis machine under laparoscopy

  • Totally Laparoscopic Middle Segmental Gastrectomy (TLMSG)Procedure or surgery

    Intervention Name: Totally Laparoscopic Middle Segmental Gastrectomy (TLMSG) Description: The intervention is a function-preserving surgical procedure performed on adult patients (age ≥ 20) diagnosed with mid- or high-body gastric adenocarcinoma with a tumor size of 4 cm or less

    • Eligible clinical stages include cT1N0/1M0 (any differentiation) or cT2N0/1M0 (well or moderately differentiated)

    The specific surgical steps and extent include:

    Resection and Preservation: The middle segment of the stomach is resected while maintaining a minimum 2-3 cm resection margin from the tumor

    • To preserve digestive function and minimize dumping syndrome, the pylorus and the upper portion of the stomach (cardia and fundus) are preserved

    Vascular Preservation: Vascular branches along the lesser and greater curvature are spared, specifically the right gastroepiploic artery and the left gastroepiploic artery

    . Lymph Node (LN) Dissection: The extent of LN excision includes stations Nos. 1, 3, 4sb, 4d

Study groups in NCT07899697
Study groupRoleWhat they receive
Totally Laparoscopic Middle Segmental Gastrectomy (TLMSG)ExperimentalThis is a function-preserving surgery that involves resecting the middle portion of the stomach while preserving the pylorus and the upper stomach (cardia and fundus) . The middle segment is resected with a minimum 2-3 cm margin from the tumor . Specific vascular branches are preserved, including the right and left gastroepiploic arteries . The lymph node dissection includes stations Nos. 1, 3, 4sb, 4d, 7, 8a, and 9, while omitting stations Nos. 5 and 6 . Reconstruction is performed using a modified delta-shaped anastomosis with a straight automated anastomosis machine under laparoscopy . This intervention aims to evaluate the safety and clinical applicability of preserving digestive functions to minimize postoperative issues like dumping syndrome and nutritional deficiencies .
Receives: Procedure: Totally Laparoscopic Middle Segmental Gastrectomy (TLMSG)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Dumping Syndrome at 1 Year Postoperatively (Sigstad Score ≥7)

    Assessed using the Sigstad score questionnaire, where a total score of 7 or higher is defined as dumping syndrome (scores < 7 indicate non-dumping)

    Measured: 1 year postoperatively

Secondary outcomes (6)
  1. Postoperative reflux symptoms.

    Subjective reflux symptoms categorized by Visick score (Grades I-IV) and endoscopic findings of reflux esophagitis categorized by the Los Angeles (LA) classification

    Measured: Preoperatively, and at 3, 12, 24, and 36 months postoperatively

  2. Postoperative Changes in Nutritional Indicators

    Nutritional status will be evaluated by assessing changes in key parameters (body weight, hemoglobin, fasting blood glucose, serum iron, vitamin B12, albumin, and total protein) measured as the percent change from preoperative baseline at each follow-up visit. Longitudinal changes from preoperative baseline through 36 months postoperatively will be analyzed using a linear mixed-effects model.

    Unit of Measure: Percent change from baseline (%)

    Measured: Preoperatively, and at 3, 6, 12, 18, 24, 30, and 36 months postoperatively

  3. Incidence of Postoperative Complications

    Early and late postoperative complications classified according to the Clavien-Dindo classification system and Comprehensive Complication Index (CCI)

    Measured: Within 30 days postoperatively (for early complications) and up to 36 months postoperatively (for late complications)

  4. 30-Day Postoperative Mortality

    Incidence of mortality occurring within 30 days of surgery

    Measured: Within 30 days postoperatively

  5. Postoperative Quality of Life (QOL)

    Assessed using EORTC QLQ-C30 (functional and symptom scales) and EORTC QLQ-STO22 (gastric cancer-specific module) questionnaires

    Measured: Preoperatively, and at 3, 12, 24, and 36 months postoperatively

  6. 3-Year Disease-Free Survival (DFS) and Overall Survival (OS)

    DFS (time from surgery to recurrence or death) and OS (time from surgery to death) estimated using the Kaplan-Meier method

    Measured: 3 years postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2026
  2. Study start15 Jun 2025
  3. Primary completion14 Jun 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
The study follows an interventional, prospective, and multicenter design * The intervention model is specifically a Single Group Assignment, meaning all enrolled participants receive the same surgical procedure, Middle Segmental Gastrectomy (MSG) * As a Phase 2 feasibility study, the design focuses on evaluating safety and clinical applicability rather than a randomized comparison within the trial * Instead of a concurrent control arm, the study utilizes a one-sample proportion test to evaluate efficacy * This statistical model compares the 1-year postoperative incidence of dumping syndrome in the MSG group against a historical control of 15.8%, which was the rate reported for standard laparoscopic distal gastrectomy in the KLASS 04 study * The research aims to enroll 78 subjects to achieve 80% power at a 0.05 significance level, assuming a conservative 5% incidence rate for the MSG procedure to demonstrate its potential benefits
Masking
None (open label)
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07899697
Sponsor's protocol ID
NCC2025-0169
Acronym
MSG
Status last verified
Oct 2026
First submitted
7 Oct 2026
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Totally Laparoscopic Middle Segmental Gastrectomy (TLMSG) in people with Gastric Cancer and Gastric Adenocarcinoma, run by National Cancer Center, Korea at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Dumping Syndrome at 1 Year Postoperatively (Sigstad Score ≥7) (time frame: 1 year postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in