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Comparison of Partial Stomach-Partitioning and Conventional Gastrojejunostomy for the Treatment of Gastric Outlet Obstruction in Advanced Gastric Cancer

2026年9月16日 更新者:Wu Liucheng、Guangxi Medical University

A Multicenter Randomized Controlled Trial Comparing the Safety and Efficacy of Partial Stomach-Partitioning Gastrojejunostomy (SPGJ) Versus Conventional Gastrojejunostomy (CGJ) for the Treatment of Gastric Outlet Obstruction in Advanced Gastric Cancer

The primary goal of clinical treatment is to relieve obstruction, restore oral feeding, improve nutritional status and improve quality of life in patients with advanced gastric cancer outflow tract obstruction. At present, the common surgical treatment for relieving obstruction is traditional gastrojejunostomy. Although the operation can relieve the obstruction, there are problems such as tumor-induced bleeding, anastomotic invasion, and high incidence of delayed gastric emptying after operation. Partitioned gastrojejunostomy effectively relieves obstruction by anastomosis of a part of the stomach to the jejunum, and isolates the tumor from the anastomosis, which is beneficial to food emptying and can reduce the risk of bleeding and anastomotic invasion. The safety and efficacy of these two procedures are still controversial, mainly because previous studies were retrospective studies or included a small sample size or enrolled patients with different pathological characteristics. The purpose of this study was to compare the safety and efficacy of separated and traditional gastrojejunostomy in the treatment of advanced gastric cancer outflow tract obstruction, and to provide the best choice for the treatment of advanced gastric cancer outflow tract obstruction.

調査の概要

詳細な説明

This study is a prospective, multi-center randomized controlled study. Patients with advanced distal gastric cancer with outflow tract obstruction ( clinical stage T4bN + M0 / T3-4N + M1, stage IV ) were enrolled. The outflow tract obstruction was confirmed by upper gastrointestinal angiography. Patients who underwent gastrojejunostomy after preoperative evaluation. After enrollment, the patients were randomly divided into SPGJ group or CGJ group according to the ratio of 1 : 1 by random number table. This study was designed for evaluators ' blinding. Imaging experts who are responsible for determining the primary endpoint ( delayed gastric emptying classification, GOOSS score ), researchers who are responsible for collecting patient-reported outcomes ( such as quality of life questionnaires ), and statisticians who perform final data analysis will be unaware of the patient 's grouping information. This study was divided into four stages : screening period, operation period, medical treatment period and follow-up period.

研究の種類

介入

入学 (推定)

80

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:Yuzhou Qin
  • 電話番号:+867715310421
  • メール:qyz402@126.com

研究連絡先のバックアップ

研究場所

    • Guangxi
      • Nanning、Guangxi、中国、530021
        • 募集
        • Guangxi Medical University Cancer Hospital
        • コンタクト:
          • Yuzhou Qin, Ph.D
          • 電話番号:+867715310421
          • メール:qyz402@126.com
        • 主任研究者:
          • Yuzhou Qin, Ph.D
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

1.Patients and their families were fully aware of this study and voluntarily signed informed consent ; 2.Age 18-75 years old ( including 18 and 75 years old ) ; 3.Distal gastric cancer ( cT4bN + M0 / T3-4N + M1, stage IV ) with locally unresectable, distant metastasis or peritoneal metastasis confirmed by pathology and unable to undergo radical surgery ; 4.Complicated with digestive tract obstruction ( gastric retention confirmed by upper gastrointestinal radiography or gastroscopy, and GOOSS score ≤ 1 ) ; the ECOG score was 0-2 points, and there was no deterioration within 7 days ; 6.ASA score I-III ; 7.No previous anti-tumor therapy ( such as radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc. ) :

The functions of important organs meet the following requirements :

(a) absolute neutrophil count ≥ 1.5 × 109 / L, white blood cell count ≥ 4.0 × 109/L; (b) Platelet ≥ 100 × 109 / L ; (c) Hemoglobin ≥ 60g / L ; (d) TBIL ≤ 1.5 times ULN ; (e) ALT and AST ≤ 2.5 times ULN ; (f) urea / urea nitrogen ( BUN ) and creatinine ( Cr ) ≤ 1.5 × ULN ( and creatinine clearance rate ( CCr ) ≥ 50mL / min ) ; (g) Left ventricular ejection fraction ( LVEF ) ≥ 50 % ; the corrected QT interval ( QTcF ) by Fridericia method was less than 470 ms. (i) INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN. 9. women of childbearing age need to take effective contraceptive measures ; 10.No other surgical contraindications ; 11.good compliance, with follow-up.

Exclusion Criteria:

  1. Unable to comply with the research program or research procedures ;
  2. Patients with other malignant tumors within 5 years before enrollment, except for basal cell or squamous cell carcinoma of the skin after radical resection, or cervical carcinoma in situ ;
  3. Patients with active autoimmune diseases or a history of autoimmune diseases within 4 weeks before enrollment ;
  4. Previously received allogeneic bone marrow transplantation or organ transplantation ;
  5. Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment ; congestive heart failure New York Heart Association ( NYHA ) grade > 2 ; ventricular arrhythmia requiring drug treatment ; lVEF ( left ventricular ejection fraction ) < 50 % ;
  6. Active or uncontrolled severe infection ( ≥ CTCAE V5.0 grade 2 infection ) ;
  7. Known human immunodeficiency virus ( HIV ) infection. Patients with known clinical history of liver disease, including viral hepatitis [ known as hepatitis B virus ( HBV ) carriers must be excluded from active HBV infection, that is, HBV DNA positive ( > 1 × 104 copies / mL or > 2000 IU / ml ) ; it is known that hepatitis C virus infection ( HCV ) and HCV RNA positive ( > 1 × 103 copies / mL ) ;
  8. pregnant ( pregnancy test positive before medication ) or breastfeeding women ;
  9. Any other disease with clinically significant metabolic abnormalities, physical examination abnormalities or laboratory abnormalities, according to the judgment of the researchers, it is reasonable to suspect that the patient has a state that is not suitable for enrollment ( such as having seizures and requiring treatment ), or will affect the interpretation of the results of the study, or put the patient at high risk ; the researchers considered that the patients were not suitable for inclusion in this study.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:単一グループの割り当て
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的:stomach-partitioning gastrojejunostomy
At the junction of the gastric body and the antrum, or about 5cm from the upper edge of the tumor, a straight-line cutting closure device was used to cut off part of the gastric body from the greater curvature of the stomach to form a partition, and a 2-3cm wide gastric body near the lesser curvature was retained. A hole was made in the greater curvature of the posterior gastric wall at the proximal end of the septum, and a hole was made in the jejunum-to-mesenteric margin 5-10 cm from the Treitz ligament. A linear cutting closure device was placed through the transverse colon. The greater curvature-jejunum side-to-side anastomosis of the posterior gastric wall with pro-peristalsis or anti-peristalsis was performed, and the common opening was closed by using a linear cutting closure device or suture.
At the junction of the gastric body and the antrum, or about 5cm from the upper edge of the tumor, a straight-line cutting closure device was used to cut off part of the gastric body from the greater curvature of the stomach to form a partition, and a 2-3cm wide gastric body near the lesser curvature was retained. A hole was made in the greater curvature of the posterior gastric wall at the proximal end of the septum, and a hole was made in the jejunum-to-mesenteric margin 5-10 cm from the Treitz ligament. A linear cutting closure device was placed through the transverse colon. The greater curvature-jejunum side-to-side anastomosis of the posterior gastric wall with pro-peristalsis or anti-peristalsis was performed, and the common opening was closed by using a linear cutting closure device or suture.
実験的:conventional gastrojejunostomy
The lowest point of the greater curvature of the stomach and the proximal jejunum 5-10 cm away from the Treitz ligament were subjected to side-to-side anastomosis of peristaltic or anti-peristaltic using a linear cutter before the transverse colon, and the common opening was closed using a linear cutter or suture.
The lowest point of the greater curvature of the stomach and the proximal jejunum 5-10 cm away from the Treitz ligament were subjected to side-to-side anastomosis of peristaltic or anti-peristaltic using a linear cutter before the transverse colon, and the common opening was closed using a linear cutter or suture.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Incidence of delayed gastric emptying(DGE)
時間枠:Evaluation time of delayed gastric emptying : day 3, day 7, day 14, day 21.after operation.
Percentage of patients with delayed gastric emptying after surgery
Evaluation time of delayed gastric emptying : day 3, day 7, day 14, day 21.after operation.

二次結果の測定

結果測定
メジャーの説明
時間枠
PG-SGA score
時間枠:Approximately 30 days
PG-SGA assessment table contains seven aspects, which are divided into two parts : the patient self-assessment part ( A score ) and the medical staff assessment part ( B + C + D score ). The total score is obtained by adding the two parts.
Approximately 30 days
Early postoperative complication rate
時間枠:Within 21 days after surgery
The probability of complications within 21 days after surgery ( including prolonged hospital stay and rehospitalization ).
Within 21 days after surgery
Late postoperative complication rate
時間枠:21 days after operation
Probability of complications 21 days after surgery
21 days after operation
Anastomotic complication rate
時間枠:Within 21 days after surgery
The probability of postoperative anastomotic complications including anastomotic stenosis and anastomotic bleeding.
Within 21 days after surgery
postoperative mortality
時間枠:Within 90 days after surgery
The probability of death within 90 days after surgery, regardless of the cause of death after surgery.
Within 90 days after surgery
Overall survival ( OS )
時間枠:Approximately weeks 1 - 2 after surgery
Overall survival time from surgery to death of any cause
Approximately weeks 1 - 2 after surgery
Life quality evaluation (QLQ-c30)
時間枠:Before operation and 1 week, 2 weeks, 4 weeks after operation and before the first systematic treatment after operation.
The QLQ-C30 ( core scale ) had a total of 30 items, using a 4-level score ( 1-4 points ). After standardization, the score range of each dimension was 0-100. The higher the score, the better the quality of life ( functional dimension ) or the more severe the symptoms ( symptom dimension ).
Before operation and 1 week, 2 weeks, 4 weeks after operation and before the first systematic treatment after operation.

その他の成果指標

結果測定
メジャーの説明
時間枠
quality of life (QLQ-STO22)
時間枠:Before operation and 1 week, 2 weeks, 4 weeks after operation and before the first systematic treatment after operation.
QLQ-STO22 ( gastric cancer-specific module ) uses a 5-level score ( 1-5 points ). The higher the score, the more severe the symptoms or the worse the quality of life.
Before operation and 1 week, 2 weeks, 4 weeks after operation and before the first systematic treatment after operation.

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スポンサー

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年10月20日

一次修了 (推定)

2028年1月1日

研究の完了 (推定)

2029年1月1日

試験登録日

最初に提出

2026年4月26日

QC基準を満たした最初の提出物

2026年4月26日

最初の投稿 (実際)

2026年5月1日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月17日

QC基準を満たした最後の更新が送信されました

2026年9月16日

最終確認日

2026年9月1日

詳しくは

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個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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いいえ

米国FDA規制機器製品の研究

いいえ

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