- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07561073
Comparison of Partial Stomach-Partitioning and Conventional Gastrojejunostomy for the Treatment of Gastric Outlet Obstruction in Advanced Gastric Cancer
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
Přehled studie
Postavení
Podmínky
Detailní popis
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Yuzhou Qin
- Telefonní číslo: +867715310421
- E-mail: qyz402@126.com
Studijní záloha kontaktů
- Jméno: Liucheng Wu
- Telefonní číslo: 13737146973
- E-mail: wuliucheng@gxmu.edu.cn
Studijní místa
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Guangxi
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Nanning, Guangxi, Čína, 530021
- Nábor
- Guangxi Medical University Cancer Hospital
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Kontakt:
- Yuzhou Qin, Ph.D
- Telefonní číslo: +867715310421
- E-mail: qyz402@126.com
-
Vrchní vyšetřovatel:
- Yuzhou Qin, Ph.D
-
Kontakt:
- Liucheng Wu, Ph.D
- Telefonní číslo: 13737146973
- E-mail: wuliucheng@gxmu.edu.cn
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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:
- Unable to comply with the research program or research procedures ;
- 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 ;
- Patients with active autoimmune diseases or a history of autoimmune diseases within 4 weeks before enrollment ;
- Previously received allogeneic bone marrow transplantation or organ transplantation ;
- 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 % ;
- Active or uncontrolled severe infection ( ≥ CTCAE V5.0 grade 2 infection ) ;
- 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 ) ;
- pregnant ( pregnancy test positive before medication ) or breastfeeding women ;
- 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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.
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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.
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Experimentální: 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.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Incidence of delayed gastric emptying(DGE)
Časové okno: Evaluation time of delayed gastric emptying : day 3, day 7, day 14, day 21.after operation.
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Percentage of patients with delayed gastric emptying after surgery
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Evaluation time of delayed gastric emptying : day 3, day 7, day 14, day 21.after operation.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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PG-SGA score
Časové okno: Approximately 30 days
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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.
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Approximately 30 days
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Early postoperative complication rate
Časové okno: Within 21 days after surgery
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The probability of complications within 21 days after surgery ( including prolonged hospital stay and rehospitalization ).
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Within 21 days after surgery
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Late postoperative complication rate
Časové okno: 21 days after operation
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Probability of complications 21 days after surgery
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21 days after operation
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Anastomotic complication rate
Časové okno: Within 21 days after surgery
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The probability of postoperative anastomotic complications including anastomotic stenosis and anastomotic bleeding.
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Within 21 days after surgery
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postoperative mortality
Časové okno: Within 90 days after surgery
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The probability of death within 90 days after surgery, regardless of the cause of death after surgery.
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Within 90 days after surgery
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Overall survival ( OS )
Časové okno: Approximately weeks 1 - 2 after surgery
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Overall survival time from surgery to death of any cause
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Approximately weeks 1 - 2 after surgery
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Life quality evaluation (QLQ-c30)
Časové okno: Before operation and 1 week, 2 weeks, 4 weeks after operation and before the first systematic treatment after operation.
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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 ).
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Before operation and 1 week, 2 weeks, 4 weeks after operation and before the first systematic treatment after operation.
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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quality of life (QLQ-STO22)
Časové okno: Before operation and 1 week, 2 weeks, 4 weeks after operation and before the first systematic treatment after operation.
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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.
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Before operation and 1 week, 2 weeks, 4 weeks after operation and before the first systematic treatment after operation.
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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