Идёт набор NCT07681128

The Effect of Braun Anastomosis on Delayed Gastric Emptying (DGE) in Reconstruction After Pancreaticoduodenectomy

Без фазы С лечением Periampullary Carcinoma Resectable

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: Braun anastomosis on delayed gastric emptying (DGE) in reconstruction after pancreaticoduodenectomy, Patients undergo PD with standard antecolic Billroth II reconstruction without Braun enteroenterostomy..
Кому может быть актуально: Состояния в реестре: Periampullary Carcinoma Resectable. Базовые параметры: от 18 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 →

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Официальное название

The Effect of Braun Anastomosis on Delayed Gastric Emptying (DGE) in Reconstruction After Pancreaticoduodenectomy: A Prospective Single-center Randomized Controlled Trial

Обзор

Pancreaticoduodenectomy (PD) is the only curative procedure for periampullary malignant tumors. Although modern perioperative management has greatly reduced postoperative mortality, delayed gastric emptying (DGE) remains one of the most common and troublesome complications after PD, with an incidence up to 30%. DGE leads to abdominal distension, nausea, vomiting, intolerance of oral diet, prolonged hospital stay, increased medical costs, delayed adjuvant therapy initiation, and impaired long-term nutritional recovery and quality of life. Braun anastomosis (BE) can reconstruct the gastrointestinal tract by side-to-side jejunojejunostomy between the afferent and efferent limbs, which may reduce intestinal stasis, bile reflux and afferent limb obstruction, and theoretically lower the risk of postoperative DGE. However, current clinical studies and meta-analyses remain controversial regarding the actual efficacy of BE in preventing DGE after PD. Some studies support that BE can reduce DGE incidence, shorten hospitalization and improve postoperative recovery, while others demonstrate no statistically significant benefit, or even concern about prolonged operative time and technical difficulty. Existing evidence is limited by small sample size, retrospective design and potential selection bias, and high-quality prospective randomized controlled trials are still lacking to confirm the clinical value of BE. This study is designed as a prospective, single-center, randomized controlled trial, aiming to evaluate the impact of routine Braun anastomosis during digestive tract reconstruction on the incidence and severity of postoperative DGE in patients undergoing pancreaticoduodenectomy for malignant tumors. The results will provide high-level clinical evidence for the rational application of Braun anastomosis in PD reconstruction and guide standardized clinical practice.

Вмешательства

Процедура Braun anastomosis on delayed gastric emptying (DGE) in reconstruction after pancreaticoduodenectomy
Intervention Group: Patients undergo PD with antecolic Billroth II reconstruction plus Braun enteroenterostomy (BE).
Процедура Patients undergo PD with standard antecolic Billroth II reconstruction without Braun enteroenterostomy.
Patients undergo PD with standard antecolic Billroth II reconstruction without Braun enteroenterostomy.

Первичные конечные точки

Incidence of delayed gastric emptying (DGE) [Срок оценки: Postoperative days 1, 8, 15, and 22]

Вторичные конечные точки (6)

Length of hospital stay (days) [Срок оценки: From first postoperative day to hospital discharge up to 15 weeks]
Treatment cost [Срок оценки: From the first postoperative day to one year follow-up]
Postoperative recovery [Срок оценки: From the first postoperative day to one year follow-up]
Bile reflux [Срок оценки: Assessment of bile reflux by 24-hour intragastric bilirubin monitoring.]
Proportion of severe complications as defined by the Clavien-Dindo classification [Срок оценки: From the first postoperative day to one year follow-up]
Quality of life scores assessed using the European Organization for Research and Treatment of Cancer (EORTC) questionnaire at 30 days postoperatively [Срок оценки: 30 days]

Критерии участия

Критерии включения

Age ≥ 18 years, male or female;
Scheduled to undergo curative pancreaticoduodenectomy (PD);
Undergoing PD for malignant or borderline tumors, with planned antecolic Billroth II reconstruction;
Mentally competent and able to provide written informed consent.