Safety of biliary drainage with 6‐mm metallic stent for preoperative obstructive jaundice in pancreatic cancer: PURPLE SIX STUDY
Rattachement africain : jp, ph. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
BACKGROUND AND AIM: The 10-mm self-expandable metal stent (SEMS) is the standard for endoscopic transpapillary biliary drainage before pancreatic cancer surgery. However, the efficacy of stents thinner than 10 mm has not been adequately validated. Therefore, we aimed to evaluate the safety of a 6-mm fully covered SEMS (FCSEMS) for distal malignant biliary obstruction (DMBO) during preoperative chemotherapy for pancreatic cancer. METHODS: This was a single-arm, multicenter, prospective phase II study of endoscopic transpapillary initial biliary drainage for DMBO before pancreatic cancer surgery. The primary endpoint was stent-related adverse events, and the key secondary endpoint was the non-recurrent biliary obstruction (non-RBO) rate during the observation period for both resectable (R) and borderline resectable (BR) pancreatic cancers. RESULTS: The study enrolled 33 patients, among whom 32 received the study treatment. There were 23 and 9 cases of R and BR pancreatic cancers, respectively. The technical and clinical success rates were 97.0% and 90.1%, respectively. The stent-related adverse event rate was 3.1% (n = 1, acute pancreatitis) (95% confidential interval, 0.00-16.2), which met the criteria to be considered safe. The overall non-RBO rate during the observation period (median 96 days) was 78.1% (82.6% and 66.7% for R and BR pancreatic cancer cases, respectively). CONCLUSIONS: The 6-mm FCSEMS is an extremely safe metallic stent with a low stent-related adverse event rate of 3.1% for preoperative biliary drainage in pancreatic cancer. It is considered the optimal stent for preoperative biliary drainage in terms of the non-RBO rate. UMIN Clinical Trial Registry (UMIN-CTR 000041704).
Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.
Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Safety of biliary drainage with 6‐mm metallic stent for preoperative obstructive jaundice in pancreatic cancer: PURPLE SIX STUDY
- Date Crossref
- 29/02/2024
- Éditeur
- Wiley
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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University of Yamanashi Department of Gastroenterology pays non établi dans la noticeUniversité ou école supérieure
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Mie University Department of Gastroenterology and Hepatology pays non établi dans la noticeUniversité ou école supérieure
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Osaka University of Pharmaceutical Sciences pays non établi dans la noticeUniversité ou école supérieure
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Tokyo Metropolitan Tama Medical Center Department of Gastroenterology and Hepatology pays non établi dans la noticeÉtablissement de santé
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Jichi Medical University Department of Gastroenterology pays non établi dans la noticeUniversité ou école supérieure
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Jichi Medical University Saitama Medical Center pays non établi dans la noticeÉtablissement de santé
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Fukuoka University Department of Gastroenterology and Medicine pays non établi dans la noticeUniversité ou école supérieure
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Mita Hospital Department of Gastroenterology pays non établi dans la noticeÉtablissement de santé
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Kumamoto University Department of Gastroenterology and Hepatology pays non établi dans la noticeUniversité ou école supérieure
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Tokyo Metropolitan Bokutoh Hospital Department of Gastroenterology pays non établi dans la noticeÉtablissement de santé
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Makati Medical Center pays non établi dans la noticeÉtablissement de santé
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Department of Hepatobiliary and Pancreatic Oncology National Cancer Center Hospital Tokyo Japan Department of Hepatobiliary and Pancreatic Oncology pays non établi dans la noticeÉtablissement de santé
Department of Gastroenterology — University of Yamanashi, Department of Gastroenterology and Hepatology — Mie University et Osaka University of Pharmaceutical Sciences, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.