Идёт набор NCT05344339

Billroth-II Modified Versus Roux-en-Y After Distal Gastrectomy for Gastric Cancer

Без фазы С лечением Gastric Cancer Distal Gastrectomy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Distal gastrectomy.
Кому может быть актуально: Состояния в реестре: Gastric Cancer, Distal Gastrectomy. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Вьетнам
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Billroth-II Modified and Roux-en-Y Reconstruction After Distal Gastrectomy for Gastric Cancer: an Open-label Randomized Control Trial

Обзор

There are Billroth-I, Billroth-II, Billroth-II with Braun, and Roux-en-Y reconstruction after distal gastrectomy. Hypothesis: Billroth-II modified method is non-inferior to Roux-en-Y method in terms of reducing reflux esophagitis after distal gastrectomy for gastric cancer patients.

Подробное описание

Since the first gastrectomy by Theodore Billroth in 1881, this procedure remained a curative treatment for gastric cancer. Reconstruction method after gastrectomy may affect complication rates, post-operative nutritional status, and quality of life (QoL). There are several reconstruction methods for distal gastrectomy, including Billroth I (B-I), Billroth II (B-II), Roux-en-Y (R-Y). B-I and B-II were considered better than R-Y in terms of shorten operation time and lessen blood loss due to technical simplicity. In contrast, R-Y was better in terms of preventing bile reflux and remnant gastritis, which can increase remnant stomach cancer and worsen QoL. However, long term QoL was similar between B-I and R-Y in some randomized controlled trials. Although bile reflux was higher in B-I and B-II groups, remnant gastric cancer was similar between 3 groups in this study. In brief, which one is the ideal reconstruction after distal gastrectomy is still controversial.

At our center, reconstruction after distal and sub-total gastrectomy including B-I, B-II, B-II with Braun anastomosis, and R-Y, depended mostly on surgeons' preferences. From 2018, to decrease bile reflux rate while not increasing operation time, we applied modified B-II technique with 3-5 sutures between the afferent loop to the gastric remnant. This study was conducted to evaluate the efficacy of this method by comparing it with the R-Y method.

Вмешательства

Процедура Distal gastrectomy
Reconstruction after Distal Gastrectomy

Первичные конечные точки

Reflux esophagistis [Срок оценки: on the 12th month after surgery]

Вторичные конечные точки (12)

Early complications [Срок оценки: 30 days after surgery]
Operative time [Срок оценки: Intraoperative]
Time for making anastomosis [Срок оценки: Intraoperative]
Blood loss [Срок оценки: Intraoperative]
Length of post-operative hospital stay [Срок оценки: 30 days after surgery or until mortality]
Post gastrectomy syndromes [Срок оценки: from 30 days to 1 years after surgery]
Bodyweight [Срок оценки: on the 3rd, 6th, and 12th month after surgery]
Serum total protein [Срок оценки: on the 3rd, 6th, and 12th month after surgery]
Serum albumin [Срок оценки: on the 3rd, 6th, and 12th month after surgery]
Hemoglobin [Срок оценки: on the 3rd, 6th, and 12th month after surgery]
Changing of Gastric remnant gastritis [Срок оценки: on the 6th, and 12th month after surgery]
Changing of Residual food [Срок оценки: on the 6th, and 12th month after surgery]

Критерии участия

Критерии включения

Patients confirmed with gastric cancer
Indicated for radical distal gastrectomy (cT1 to cT4a, any N, M0; according to AJCC/UICC 8th TNM staging for gastric cancer)
Age from 18- to 80-year-old
Agreed to participate in study with written inform consent