The Effect of Braun Anastomosis on Delayed Gastric Emptying (DGE) in Reconstruction After Pancreaticoduodenectomy
The Effect of Braun Anastomosis on Delayed Gastric Emptying (DGE) in Reconstruction After Pancreaticoduodenectomy: A Prospective Single-center Randomized Controlled Trial
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.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Yunlong Cui, PhD
- Número de telefone: +86 18622228633
- E-mail: ningyunlong@163.com
Locais de estudo
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Tianjin Municipality
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Tianjin, Tianjin Municipality, China, 300060
- Recrutamento
- Tianjin Medical University Cancer Institute & Hospital
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Contato:
- Yunlong Cui
- Número de telefone: +86 18622228633
- E-mail: ningyunlong@163.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Age < 18 years;
- Prior diagnosis of gastroparesis;
- Benign disease as the indication for PD;
- Previous history of upper gastrointestinal surgery;
- Preoperative pyloric obstruction;
- Planned pylorus-preserving pancreaticoduodenectomy (PPPD);
- Patients who have received neoadjuvant or conversion therapy;
- Preoperative glycated hemoglobin (HbA1c) > 7.5%;
- Preoperative total bilirubin level > 200 μmol/L;
- Unable or unwilling to provide written informed consent.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Braun arm
PD with Billroth II reconstruction plus Braun anastomosis
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Intervention Group: Patients undergo PD with antecolic Billroth II reconstruction plus Braun enteroenterostomy (BE).
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Outro: Non Braun Arm
PD with Billroth II reconstruction alone (without Braun anastomosis)
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Patients undergo PD with standard antecolic Billroth II reconstruction without Braun enteroenterostomy.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Incidence of delayed gastric emptying (DGE)
Prazo: Postoperative days 1, 8, 15, and 22
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Incidence of delayed gastric emptying (DGE), defined according to the International Study Group of Pancreatic Surgery (ISGPS) criteria
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Postoperative days 1, 8, 15, and 22
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Length of hospital stay (days)
Prazo: From first postoperative day to hospital discharge up to 15 weeks
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Comparison of hospital stay duration between the intervention group and the control group.
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From first postoperative day to hospital discharge up to 15 weeks
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Treatment cost
Prazo: From the first postoperative day to one year follow-up
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Evaluation of the difference in medical expenditure between the intervention group and the control group.
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From the first postoperative day to one year follow-up
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Postoperative recovery
Prazo: From the first postoperative day to one year follow-up
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Including time to first flatus, time to oral intake, and other related indicators.
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From the first postoperative day to one year follow-up
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Bile reflux
Prazo: Assessment of bile reflux by 24-hour intragastric bilirubin monitoring.
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Assessment of bile reflux by 24-hour intragastric bilirubin monitoring.
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Proportion of severe complications as defined by the Clavien-Dindo classification
Prazo: From the first postoperative day to one year follow-up
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From the first postoperative day to one year follow-up
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Quality of life scores assessed using the European Organization for Research and Treatment of Cancer (EORTC) questionnaire at 30 days postoperatively
Prazo: 30 days
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30 days
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Colaboradores e Investigadores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Braun-HCC
Plano para dados de participantes individuais (IPD)
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