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临床试验/NCT06301048
NCT06301048已完成不适用

Effectiveness of Endoscopic Papillectomy With Stent Placement in Pancreatic and Bile Ducts for Treating Duodenal Papillary Adenoma

Beijing Friendship Hospital1 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2023年11月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
79
试验地点
1
主要终点
Rate of complete resection

研究概览

简要总结

This is a retrospective study, including 79 patients with duodenal papillary adenoma, who treated with Endoscopic Papillectomy (EP) at Beijing friendship hospital. The cohort included patients who underwent EP with or without Pancreatic Duct (PD) and Common Bile Duct (CBD) stent placement. The investigators assessed the outcomes of EP and the impact of stent placement on complications and recurrence rates.

详细描述

Duodenal papillary adenoma, a potentially malignant benign tumor is primarily treated with endoscopic papillectomy. Despite its efficacy, endoscopic papillectomy has a high complication rate. This study investigates whether pancreatic duct and common bile duct stent placement can mitigate these complications. In a retrospective analysis, 79 patients with duodenal papillary adenoma, treated with endoscopic papillectomy at our center, were studied. The cohort included patients who underwent endoscopic papillectomy with no stents placement, common bile duct stent placement alone, pancreatic duct stent placement alone, or stents placement in both ducts. Complete resection rates did not significantly differ between patients with or without stent placement. Early complication rates were similar across groups. However, significant reduction in common bile duct stenosis was observed in the stenting group. Furthermore, stent placement correlated with lower adenoma recurrence rates during follow-up. Thus, Pancreatic duct and common bile duct stent placement in endoscopic papillectomy may decrease late complications, particularly common bile duct stenosis, and reduce the recurrence of duodenal papillary adenoma.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years.
  • Identification of duodenal papillary lesions via gastroscopy or duodenoscopy.
  • Intraductal involvement <20mm.
  • Absence of preoperative peripheral lymph node metastasis and pancreatic/biliary duct stenosis (verified by CT, MRI, or other imaging).
  • Postoperative biopsy confirming adenoma.

排除标准

  • Diagnosis of familial adenomatous polyposis or multiple hamartoma syndrome.
  • Patients undergoing pancreaticoduodenectomy within a month post-EP for residual lesions.

结局指标

主要结局

Rate of complete resection

时间窗: 1 week after the operation

The pathological margins results were used to determine whether the lesion was completely resected.

Rate of complications

时间窗: through study completion, an average of 1 year

Complications related with Endoscopic Papillectomy (EP), including pancreatitis, cholangitis, bleeding, perforation, hyperamylasemia, stenosis. The results of intraoperative endoscopic observation, postoperative symptoms and signs, blood routine examination, amylase, lipase, and imaging and endoscopic examination during follow-up were measured.

次要结局

  • Rate of recurrence(Within 3 years after the operation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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