Belépés

NCT07260461Toborzás még nem indult

The Efficacy and Safety of Laparoscopic Proximal Gastrectomy With LPG-tbROSF Versus LTG for Localized Proximal Gastric Cancer.

A Multicenter, Prospective, Randomized Controlled Clinical Trial on the Efficacy and Safety of Laparoscopic Proximal Gastrectomy With Tubular Stomach-Based Right-Opening Single Flap Valvuloplasty (LPG-tbROSF) Versus Laparoscopic Total Gastrectomy for Localized Proximal Gastric Cancer.

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. dec. 3.

Rövid összefoglaló (regiszter, angolul)

This clinical trial is evaluating a new, function-preserving surgical technique for patients with early-stage cancer in the upper part of the stomach. The current standard treatment is a Laparoscopic Total Gastrectomy (LTG), which involves the complete removal of the stomach. This study compares the standard LTG with an innovative procedure called Laparoscopic Proximal Gastrectomy combined with a novel anti-reflux reconstruction (LPG-tbROSF). This new technique removes only the cancerous upper portion of the stomach, aiming to preserve digestive functions and reduce post-surgery complications like acid reflux. The main goal is to see if patients who receive the new, stomach-preserving surgery experience less body weight loss one year after the procedure compared to those who undergo the standard total gastrectomy. The research will also compare the two surgeries in terms of post-operative quality of life, nutritional status, acid reflux symptoms, safety, and long-term cancer outcomes. The study is a multi-center, prospective, randomized controlled trial that plans to enroll 120 patients with localized cancer in the upper stomach.

Állapot (regiszter)
Toborzás még nem indult
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
120 (tervezett)
Első benyújtás
2025. szept. 10.
Kezdés
2026. jan. 1.
Elsődleges befejezés
2027. szept. 1.
Fő szponzor
First Affiliated Hospital of Wenzhou Medical University
NCT-szám
NCT07260461

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Tervezett résztvevők: 120
  • 2026. jan. 1. és az elsődleges befejezés (2027. szept. 1.) között
  • Nincs megadott helyszín, ország nélkül
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

Ki nem vehet részt

Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.

Korábbi kezelés

  • Previous major gastric or upper abdominal surgery (such as subtotal gastrectomy, esophagogastric anastomosis, etc.) affecting the reconstruction method;
  • Received preoperative neoadjuvant chemoradiotherapy or targeted therapy (unless specifically permitted by the study design);

Más betegség

  • Concurrent with other active malignant tumors, or a history of other malignant tumors within 5 years (excluding basal cell carcinoma of the skin and carcinoma in situ of the cervix);
  • Severe cardiovascular diseases: such as NYHA class Ⅲ and above cardiac dysfunction, recent myocardial infarction (within 6 months), refractory hypertension or arrhythmia;
  • Severe respiratory diseases: severe impairment of lung function (FEV1%\<50%) or chronic respiratory failure;
  • patients complicated with other major chronic diseases, such as active tuberculosis, rheumatoid, systemic lupus erythematosus and other autoimmune diseases that affect surgical tolerance;
  • Complicated with other upper gastrointestinal diseases, such as active gastric ulcer, pyloric obstruction, persistent bleeding, which seriously affect the operation;
  • Patients with mental disorders, cognitive impairment, poor compliance, inability to understand the study content, or inability to cooperate with the follow-up;
  • Other individual conditions deemed unsuitable for enrollment by the investigator (e.g., poor willingness to cooperate, high risk of loss to follow-up, etc.).

Laborértékek

  • Severe liver and kidney dysfunction: ALT/AST \> 3 times the upper limit of normal, or eGFR \< 30 mL/min/1.73m²;
  • Severe malnutrition before surgery: BMI \< 16 kg/m² or albumin \< 25 g/L;

Egyéb

  • Tumor imaging suggested the presence of distant metastasis (M1) or regional lymph node involvement, and the tumor was unresectable.
  • Pregnant or lactating women;

Kiket keres a vizsgálat

  • Aged from 18 to 75 years old;
  • Histologically confirmed proximal gastric adenocarcinoma, CT1-2N0M0 stage;
  • The tumor was located in the proximal third of the stomach.
  • ECOG score of 0 or 1;
  • D1+ or D2 dissection according to guidelines (depending on tumor location and intraoperative evaluation).
  • ASA grade I to III;
  • The preoperative nutritional status of the patients was good without severe malnutrition.
  • Voluntarily sign informed consent.

Életkor a regiszterben: 15 év – 75 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.