Ligation of the Pancreatic Stump With Quantified Force During Distal Pancreatectomy for Postoperative Pancreatic Fistula: Protocol for a Single-Center Nonrandomized Controlled Clinical Study
Notice bibliographique
Résumé
BACKGROUND: The incidence of postoperative pancreatic fistula following distal pancreatectomy is as high as 30%-50%. Postoperative pancreatic fistula can be a major cause of perioperative morbidity, resulting in prolonged hospital stays and increased health care costs. The management of the pancreatic stump is one of the key factors influencing the occurrence of postoperative pancreatic fistula after distal pancreatectomy, but the optimal management approach remains debatable. The main methods for pancreatic stump closure include manual suturing and stapler closure. However, both methods are associated with a high risk of postoperative pancreatic fistula, which may be related to the balance between providing sufficient pancreatic duct burst pressure and ensuring blood supply to the stump. Ligation of the pancreatic stump has been attempted to reduce the risk of postoperative pancreatic fistula following distal pancreatectomy, but its efficacy remains limited by the challenge of achieving the optimal ligation force. OBJECTIVE: This study aims to investigate whether ligation of the pancreatic stump with a quantified force can decrease the risk of postoperative pancreatic fistula following distal pancreatectomy. METHODS: In this nonrandomized controlled clinical study at a tertiary center in China, the major eligibility criterion is the presence of lesions planned for distal pancreatectomy. Sixty patients will be allocated to the experimental or control group according to their choice. Recruitment for either group will be discontinued upon reaching the predefined sample size of 30 participants. In the experimental group, the pancreas will be ligated 5 mm from the pancreatic stump with a quantified force to provide a pancreatic duct burst pressure of approximately 40-70 mm Hg. The ligation force will be provided by a 3.2-mm-diameter silicone ring. During pancreatic stump ligation, this silicone ring will be stretched to 15 mm, generating an applied force of 1.3 N. The pancreas will be severed using energy-based devices before or after the ligation. In the control group, the pancreatic stump will be managed by manual suturing or stapling closure according to the surgeon's clinical judgment and preference. Postoperative regular follow-up examinations will be conducted. The primary outcomes include postoperative pancreatic fistula and postoperative hospital stay, and the secondary outcomes include intra-abdominal infection, incision infection, and postoperative treatment costs. The primary and secondary outcomes of patients in this cohort will be statistically compared using appropriate tests. RESULTS: This study started in February 2025, and the recruitment period is from February to September 2025. CONCLUSIONS: This protocol proposes a novel approach for pancreatic stump management aimed at preventing postoperative pancreatic fistula following distal pancreatectomy. The research team established the optimal ligation force for the pancreatic stump to ensure adequate burst pressure for the pancreatic duct while preventing acute stump necrosis, thereby theoretically reducing the risk of postoperative pancreatic fistula. TRIAL REGISTRATION: Chinese Clinical Trial Register ChiCTR2500097781; https://www.chictr.org.cn/showproj.html?proj=247008. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/74018.
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Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,025 | 0,013 |
| Méta-épidémiologie (sens strict) | 0,005 | 0,002 |
| Méta-épidémiologie (sens large) | 0,010 | 0,003 |
| Bibliométrie | 0,002 | 0,002 |
| Études des sciences et des technologies | 0,003 | 0,004 |
| Communication savante | 0,002 | 0,002 |
| Science ouverte | 0,003 | 0,002 |
| Intégrité de la recherche | 0,005 | 0,004 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,021 | 0,004 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».