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

31 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

80

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Yuzhou Qin
  • Numero di telefono: +867715310421
  • Email: qyz402@126.com

Backup dei contatti dello studio

Luoghi di studio

    • Guangxi
      • Nanning, Guangxi, Cina, 530021
        • Reclutamento
        • Guangxi Medical University Cancer Hospital
        • Contatto:
          • Yuzhou Qin, Ph.D
          • Numero di telefono: +867715310421
          • Email: qyz402@126.com
        • Investigatore principale:
          • Yuzhou Qin, Ph.D
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Sperimentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of delayed gastric emptying(DGE)
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
PG-SGA score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 21 days after operation
Probability of complications 21 days after surgery
21 days after operation
Anastomotic complication rate
Lasso di tempo: Within 21 days after surgery
The probability of postoperative anastomotic complications including anastomotic stenosis and anastomotic bleeding.
Within 21 days after surgery
postoperative mortality
Lasso di tempo: 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 )
Lasso di tempo: 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)
Lasso di tempo: 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.

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
quality of life (QLQ-STO22)
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 gennaio 2026

Completamento primario (Stimato)

1 gennaio 2028

Completamento dello studio (Stimato)

1 gennaio 2029

Date di iscrizione allo studio

Primo inviato

26 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

26 aprile 2026

Primo Inserito (Effettivo)

1 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

31 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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