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

16 września 2026 zaktualizowane przez: 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.

Przegląd badań

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

80

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Yuzhou Qin
  • Numer telefonu: +867715310421
  • E-mail: qyz402@126.com

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

    • Guangxi
      • Nanning, Guangxi, Chiny, 530021
        • Rekrutacyjny
        • Guangxi Medical University Cancer Hospital
        • Kontakt:
          • Yuzhou Qin, Ph.D
          • Numer telefonu: +867715310421
          • E-mail: qyz402@126.com
        • Główny śledczy:
          • Yuzhou Qin, Ph.D
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Eksperymentalny: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Incidence of delayed gastric emptying(DGE)
Ramy czasowe: 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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
PG-SGA score
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 21 days after operation
Probability of complications 21 days after surgery
21 days after operation
Anastomotic complication rate
Ramy czasowe: Within 21 days after surgery
The probability of postoperative anastomotic complications including anastomotic stenosis and anastomotic bleeding.
Within 21 days after surgery
postoperative mortality
Ramy czasowe: 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 )
Ramy czasowe: 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)
Ramy czasowe: 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.

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
quality of life (QLQ-STO22)
Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

20 października 2026

Zakończenie podstawowe (Szacowany)

1 stycznia 2028

Ukończenie studiów (Szacowany)

1 stycznia 2029

Daty rejestracji na studia

Pierwszy przesłany

26 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

26 kwietnia 2026

Pierwszy wysłany (Rzeczywisty)

1 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

17 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

16 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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