- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Yuzhou Qin
- Telefonnummer: +867715310421
- E-mail: qyz402@126.com
Undersøgelse Kontakt Backup
- Navn: Liucheng Wu
- Telefonnummer: 13737146973
- E-mail: wuliucheng@gxmu.edu.cn
Studiesteder
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Guangxi
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Nanning, Guangxi, Kina, 530021
- Rekruttering
- Guangxi Medical University Cancer Hospital
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Kontakt:
- Yuzhou Qin, Ph.D
- Telefonnummer: +867715310421
- E-mail: qyz402@126.com
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Ledende efterforsker:
- Yuzhou Qin, Ph.D
-
Kontakt:
- Liucheng Wu, Ph.D
- Telefonnummer: 13737146973
- E-mail: wuliucheng@gxmu.edu.cn
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of delayed gastric emptying(DGE)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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PG-SGA score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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 )
Tidsramme: 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)
Tidsramme: 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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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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quality of life (QLQ-STO22)
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CS2026(16)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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