Conventional Versus Stomach-Partitioning Gastrojejunostomy for Malignant Gastric Outlet Obstruction in Stage IV Gastric Cancer (KLASS 16)

Обзор

The goal of this clinical trial is to evaluate whether stomach-partitioning gastrojejunostomy (SPGJ) more effectively reduces postoperative delayed gastric emptying (DGE) compared to conventional gastrojejunostomy (CGJ) in patients with unresectable stage IV gastric cancer accompanied by malignant gastric outlet obstruction (MGOO). This multicenter randomized trial aims to establish a new surgical standard that enhances recovery and quality of life in advanced gastric cancer. The main questions are: 1. Does SPGJ significantly decrease DGE compared with CGJ? 2. Does SPGJ enable faster food tolerance, shorter hospital stay, and earlier chemotherapy? Researchers will compare two arms - SPGJ and CGJ - to determine differences in postoperative gastric emptying, hospital course, complications, and survival outcomes. Participants Eligible participants are adults aged 20-85 years with histologically proven unresectable gastric adenocarcinoma limited to the lower third of the stomach and endoscopic or radiologic evidence of obstruction. Patients with total bowel obstruction, middle-third tumor extension, emergency conditions, or severe malnutrition (albumin \< 2.5 g/L) are excluded. Interventions * CGJ arm: Standard laparoscopic gastrojejunostomy using a 60 mm stapler without partitioning. * SPGJ arm: Laparoscopic transverse gastric partitioning 5 cm proximal to the tumor with a 2 cm bridge at the lesser curvature, followed by stapled gastrojejunostomy. All operations follow standardized training videos and pretrial workshops to ensure consistency across 32 Korean university hospitals. Study Design This is a prospective, randomized controlled multicenter trial (KLASS 16). After intraoperative diagnostic laparoscopy confirms eligibility, participants are randomized by a secure web-based block system stratified by hospital. A total of 144 patients (72 per arm) will be enrolled, ensuring 90% statistical power based on expected DGE rates (CGJ 34.6% vs SPGJ 3.8%). Endpoints * Primary endpoint: Incidence of DGE within 30 days (ISGPS criteria). * Secondary endpoints: Day of oral tolerance (GOO score ≥ 2), hospital stay, Clavien-Dindo ≥ II complications, mechanical obstruction recurrence, 6 and 12 month overall survival, and quality of life. Data Collection and Analysis Data will include postoperative nutrition recovery, complication grades, and survival follow-up. Analyses will utilize Chi square or Fisher's exact test for DGE rates and Kaplan-Meier with log rank testing for survival. Logistic regression will identify DGE risk factors. Duration Total 3 years: 6 months preparation, 1 year enrollment, 1 year follow up, and 6 months for data analysis and reporting. Expected Outcomes SPGJ is expected to reduce DGE by \> 70%, shorten hospital stay by \~3 days, and enable earlier chemotherapy, thereby improving palliative care outcomes and overall patient quality of life. The KLASS 16 trial will provide the first multicenter, Level I evidence to determine whether SPGJ should replace CGJ as the standard palliative procedure for MGOO.

Вмешательства

• Процедура Conventional Gastrojejunostomy
  Traditional Laparoscopic Gastrojejunostomy
• Процедура Stomach-Partitioning
  Laparoscopic stomach partitioning (Transversely divide the stomach 5 cm or more proximal to the tumor mass, leaving an approximately 2 cm uncut space at the lesser curvature (LC) side)

Первичные конечные точки

• Comparison of the Incidence of Delayed Gastric Emptying (DGE) [Срок оценки: 30 days post-surgery]

Вторичные конечные точки (1)

• GOO Score at Postoperative Day 7. [Срок оценки: Postoperative Day 7.]

Критерии участия

Критерии включения

• Histologically confirmed gastric adenocarcinoma with Gastric Outlet Obstruction (GOO) that is unresectable for cure (e.g., surrounding tissue invasion, localized peritoneal metastasis, distant metastasis)

• Tumor location confined to the lower one-third (Low body 1/3) of the stomach ③ Age between 20 and 85 years

• ECOG Performance Status ≤ 2 ⑤ ASA score Class I to III ⑥ Endoscopic or radiologic evidence of obstructive GOO

Критерии исключения

• Patients with bowel obstruction due to extensive peritoneal metastasis (P3)

• Tumor extension beyond the lower one-third into the middle one-third of the stomach, making partitioning difficult ③ Patients requiring emergency surgery for perforation or hemorrhage ④ Severe malnutrition (serum albumin < 2.5} g/L) ⑤ Patients currently undergoing pre-operative chemotherapy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Gyeongsang National University Changwon hospital — Changwon

Публикации

• Hai NV, Thong DQ, Dat TQ, Nguyen DT, Quoc HLM, Minh TA, Anh NVT, Vuong NL, Trung TT, Bac NH, Long VD. Stomach-partitioning versus conventional gastrojejunostomy for unresectable gastric cancer with gastric outlet obstruction: A propensity score matched cohort study. Am J Surg. 2024 Feb;228:206-212. doi: 10.1016/j.amjsurg.2023.09.044. Epub 2023 Oct 1. PMID 37827868

Идентификаторы

NCT: NCT07749326 · Stomach partitioning-KLASS16

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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