Aperçu

Éligibilité

Détails de la conception

Bras et interventions

Mesures des résultats

Sites d'essai

Source : NCT06202105

Recrutement en cours

LOTA: Comparison of Laparoscopic and Open Total Gastrectomy for Locally Advanced Gastric Cancer

Interventionnel

Phase non listée

University Medical Center Ho Chi Minh City

Sponsor: University Medical Center Ho Chi Minh City (UMC)

Dernière synchronisation : 25 mars 2025
Avis - Les informations proviennent de registres publics et peuvent ne pas refléter les changements en temps réel sur le site local.

Evidence of implementation of laparoscopic total gastrectomy (LTG) for locally advanced gastric cancer (GC) remains inadequate. This study aimed to compare short- and mid-term outcomes of LTG versus open total gastrectomy (OTG) for cT2-4a GC.

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Catégorie de traitement

Procédure

Mutations requises

Aucun

Essai commencé

2 août 2024

Dernière mise à jour par le sponsor

25 mars 2025

Achèvement estimé

2 août 2032

Contact de l'étude

Éligibilité

Critères d'inclusion

* Pathologic finding by gastric endoscopy: confirmed gastric adenocarcinoma

* Age: 18 - 80 year old

* Tumor required total gastrectomy for radical treatment

* Preoperative cancer stage (CT scan stage): cT2-4aNanyM0

* ASA score: ≤ 3

* Informed consent patients (explanation about our clinical trials is provided to the patients or patrons, if patient is not available)

Critères d'exclusion

* Concurrent cancer or patient who was treated due to other cancer before the patient was diagnosed gastric cancer

* Bulky lymph node andd/or Para-aortic lymph node metastasis

* Combined esophagectomy due to invading to the esophagus

* Pregnant patient

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Détails de la conception

AllocationRandomized

Modèle d'interventionParallel Assignment

MasquageSingle

Nombre à inscrire210

Bras et interventions

Bras

Interventions

Type : Experimental

Description : 5 trocars were used. The gastrocolic ligament was divided along the border of the transverse colon. ligating the left gastroepiploic vessels to remove group 4sb. The right gastroepiploic vein was divided and right gastroepiploic and inferior pyloric artery were transected at their origin from the gastroduodenal artery to dissect group 6. The dissection was continued along the hepatoduodenal ligament to removed group 5 and group 12a and along the common hepatic artery to remove group 8a and along the celiac axis to remove group 9. The left gastric vein was divided and then the left gastric artery was vascularized to remove group 7. The dissection was continued upward along the splenic artery and its branches to remove group 11p,d and/or along the splenic hilum to remove group 10. The dissection was then conducted the right and left of the esophago-gastric junction to remove group 1,2. As a general rule, Roux en Y method was used for esophagoo-jejunal reconstruction for all cases

Interventions :

Laparoscopic gastrectomy

Mesures des résultats

Mesures des résultats primaires

3 year relapse-free survival by Kaplan Mayer3 year after surgery

The percentage of people in this study who are alive without recurrence three years after surgery.

3 year overall survival by Kaplan Mayer3 year after surgery

The percentage of people in this study who are alive three years after surgery

Mesures des résultats secondaires

operative morbidity30 days after surgery

The rate of postoperative bleeding and the rate of postoperative leakage

operative mortality30 days after surgery

The rate of postoperative dead

hospital stay30 days after surgery

The number of days between surgery and discharge

operative timeintraoperative

The duration of a surgical procedure in minutes.

Resected lymph nodesintraoperative

The number of lymph nodes harvested after surgery

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Sites d'essai

Cette étude compte 3 sites d'essai

University Medical Center Ho Chi Minh City

Ho Chi Minh City, VN

Nom:Long D. Vo, MD.

E-mail:long.vd@umc.edu.vn

Téléphone:+84918133915

Recrutement en cours

Ho Chi Minh City, 700000 VN

University Medical Center Ho Chi Minh City

Recrutement en cours

Bien Hoa, Dong Nai, 810000 VN

Dong Nai General Hospital

Pas encore en recrutement

Ha Noi, 100000 VN

108 Military Central Hospital

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