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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Yunlong Cui, PhD
- Numéro de téléphone: +86 18622228633
- E-mail: ningyunlong@163.com
Lieux d'étude
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Chine, 300060
- Recrutement
- Tianjin Medical University Cancer Institute & Hospital
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Contact:
- Yunlong Cui
- Numéro de téléphone: +86 18622228633
- E-mail: ningyunlong@163.com
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Autre: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Incidence of delayed gastric emptying (DGE)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Length of hospital stay (days)
Délai: From first postoperative day to hospital discharge up to 15 weeks
|
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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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|
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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
Délai: 30 days
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30 days
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Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Braun-HCC
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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