A Prospective Observation Registry Study on the Alimentary Reconstruction After Radical Proximal 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: Double tract reconstruction, Gastric conduit reconstruction, Other reconstructions.
- Кому может быть актуально
- Состояния в реестре: Proximal Gastric Adenocarcinoma, Reconstruction. 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
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Обзор
This study is designed as a prospective, real world registry study that compare the safety and efficacy of the different construction methods after radical proximal gastrectomy.
Подробное описание
* The patient was admitted to the hospital, and at the time of physical examination, the following conditions were met: 18 years old ≤ age ≤ 80 years old; preoperative ECOG performance status score 0/1; non-pregnant or lactating women; no serious mental illness; no serious respiratory disease; No severe hepatic and renal insufficiency; no history of unstable angina pectoris and myocardial infarction within 6 months; no history of cerebral infarction or cerebral hemorrhage within 6 months, except for old cavity infarction; no history of continuous glucocorticoid therapy (local Except for applications); pulmonary function test showed FEV1 ≥ 50% of the predicted value. The patient did not participate in other clinical studies (within 6 months).
* gastric adenocarcinoma was diagnosed by endoscopic examination and histopathological biopsy of the patient's primary lesion, including: papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly adherent carcinoma (including signet ring cell carcinoma and other types), Mixed adenocarcinoma, etc. In qualified units, endoscopic ultrasonography (EUS) is recommended. The tumor is located in the upper part of the stomach or at the esophagogastric junction (tumor diameter is less than 4cm, and the length of invasion of the esophagus is less than 2cm);
* Enhanced CT scan of the abdomen and pelvis was performed on the patient. For upper gastric cancer, no tumor invading the muscular layer, subserosal layer or serosa layer was found, and no distant metastasis occurred; for esophagogastric junction cancer, no distant metastasis occurred;
* The patient has a clear diagnosis of gastric adenocarcinoma, and it is expected that proximal gastrectomy and lymph node dissection can be performed to obtain an R0 surgical result. .
* The patient's ASA is I-III. ⑥ At this point, the patient becomes a potential selected case and enters the case selection procedure.
Вмешательства
- Процедура Double tract reconstruction
Double tract reconstruction would be applied after radical proximal gastrectomy. - Процедура Gastric conduit reconstruction
Gastric conduit reconstructionn would be applied after radical proximal gastrectomy. - Процедура Other reconstructions
Other reconstructions except for double tract and gastric conduit reconstructions would be applied after radical proximal gastrectomy.
Первичные конечные точки
- Reflux esophagitis incidence 1 year after surgery [Срок оценки: 1 year]
Вторичные конечные точки (6)
- Morbidity after surgery [Срок оценки: 30 days]
- Body weight(kg) after surgery [Срок оценки: 12 months]
- Albumin(g/L) after surgery [Срок оценки: 12 months]
- Hemoglobin(g/L) after surgery [Срок оценки: 12 months]
- 3-year relapse free survival rate [Срок оценки: 3 years]
- Mortality after surgery [Срок оценки: 30 days]
Критерии участия
Критерии включения
- Aged 18-80 years
- Tumor located in the upper or esophagogastric junction (EGJ), and curative resection with more than 1/2 remant is expected to be achievable by proximal gastrectomy with D2 lymphadenectomy (also apply to multiple primary cancers);
- Clinical stage T1NxM0 (According to AJCC-8th TNM staging system) of the upper stomach or diameter of EGJ cancer less than 4cm with invading esophgus no more than 2cm without any distant metastasis;
- Primary lesion is pathologically diagnosed as gastric adenocarcinoma, such as papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), and mixed adenocarcinoma;
- Preoperative performance status (ECOG,Eastern Cooperative Oncology Group) of 0 or 1
- Preoperative ASA (American Society of Anesthesiologists) scoring: I-III
- Sufficient organ functions
- Written informed consent
Критерии исключения
\-
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Китай · 1 центр
- Zhongshan Hospital Fudan University — Шанхай
Идентификаторы
NCT: NCT05539105 · STAR-PG01