An interventional study of Totally Laparoscopic Middle Segmental Gastrectomy (TLMSG) and Totally Laparoscopic Middle Segmental Gastrectomy (TLMSG) in Gastric Cancer, Gastric Adenocarcinoma and Middle Segmental Gastrectomy (MSG), sponsored by National Cancer Center, Korea. Active, not recruiting at 1 site in South Korea. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by National Cancer Center, Korea · Not applicable, Interventional, and Treatment
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
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.
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
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
3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.
This study's planned enrollment of 78 is above the median of 66 across 2,499 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →National Cancer Center, Korea is the lead sponsor of 204 studies on the registry; 36 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
① Diagnosed with gastric adenocarcinoma by tissue and capable of middle segmental gastrectomy by meeting the following oncologic characteristics on preoperative examination
-cT2N0 or T2N1, well-differentiated or moderately-differentiated adenocarcinoma
Adult patients age 20 and older ③ performance is between 0 and 2
class I - III
Exclusion Criteria:
Borrmann type 4 stomach cancer
Multiple gastric cancers or comorbid
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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 . This intervention aims to evaluate the safety and clinical applicability of preserving digestive functions to minimize postoperative issues like dumping syndrome and nutritional deficiencies .
Procedure: Totally Laparoscopic Middle Segmental Gastrectomy (TLMSG)
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
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
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)
Time frame: 1 year postoperatively
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
Time frame: Preoperatively, and at 3, 12, 24, and 36 months postoperatively
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 (%)
Time frame: Preoperatively, and at 3, 6, 12, 18, 24, 30, and 36 months postoperatively
Incidence of Postoperative Complications
Early and late postoperative complications classified according to the Clavien-Dindo classification system and Comprehensive Complication Index (CCI)
Time frame: Within 30 days postoperatively (for early complications) and up to 36 months postoperatively (for late complications)
30-Day Postoperative Mortality
Incidence of mortality occurring within 30 days of surgery
Time frame: Within 30 days postoperatively
Postoperative Quality of Life (QOL)
Assessed using EORTC QLQ-C30 (functional and symptom scales) and EORTC QLQ-STO22 (gastric cancer-specific module) questionnaires
Time frame: Preoperatively, and at 3, 12, 24, and 36 months postoperatively
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
Time frame: 3 years postoperatively
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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