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临床试验/NCT04317352
NCT04317352已完成不适用

Distal Pancreatectomy With Multivisceral Resection: A Multicentric Study

Universidad de Extremadura1 个研究点 分布在 1 个国家目标入组 435 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
435
试验地点
1
主要终点
Mortality

研究概览

简要总结

The objective of the study is to evaluate the characteristics of the patients and the results of morbidity and mortality after distal pancreatectomy isolated or accompanied by multivisceral resection including cholecystectomy.

详细描述

Multicenter study that includes patients operated on for distal pancreatectomy between January 2009 to December 2019 for primary pancreatic tumors. Both open or laparoscopic approaches are considered in the study. The objective is to evaluate the characteristics of the patients and the results of morbidity and mortality after distal pancreatectomy isolated or accompanied by multivisceral resection including cholecystectomy. For this, demographic data, variables related to the tumor, surgical intervention and postoperative evolution were collected.

Definitions:

Diagnosis was based mainly on computed tomography (CT scan), Magnetic Resonance (MRI) and endoscopic ultrasonography (USE) plus biopsy. Surgical technique includes open and laparoscopic approach with or without spleen preservation. Complications were assessed at 90 days using the Clavien - Dindo classification, and those defined as Clavien - Dindo grade IIIA or higher were considered major. For the recording of complications, the medical and nursing notes of the electronic or histories of each patient were consulted. For the specific complications of pancreatic surgery, the definitions of the International Study Group on Pancreatic Surgery (ISGPS) of delayed gastric emptying (21), post-pancreatic hemorrhage (22) and pancreatic fistula were used. The resection margins of the surgical specimen were categorized according to the definitions of the Royal College of Pathologists: R0 (margin to the tumor ≥ 1mm), R1 (margin to the tumor <1mm) and R2 (macroscopically positive margin) (24). Tumors were staged according to the TNM classification 8 º Ed. (TNM). Follow up scheme was: 6-month outpatient clinic visit during first five years including tumoral markers and CT/MRI. After five years only once a year visit policy was applied.

Variables The following variables were studied: Epidemiological: age, sex, past medical history, medication, Charlson Index and American Society of Anesthesiology (ASA) classification; Clinical: symptoms due to mucinous neoplasm (MCN); Serological tests: leukocytes, amylase; hemoglobin (gr/dl), bilirubin, creatinin, prothrombin time, carcinoembryonic antigen (CEA) and carbohydrate antigen (CA) 19-9; Radiological/diagnostic: diagnostic tests performed (CT/MRI/EUS), number, size and location of MCN, vascular infiltration (arterial and venous) and preoperative biopsy; Surgical: type of approach (open/laparoscopy/conversion), spleen preservation, associated procedures (organs resected), type of closure of pancreatic remnant, intraoperative bleeding (ml); postoperative course: morbidity and mortality (according to the Clavien-Dindo (CD) classification) (13), pancreatic fistula, postoperative hemorrhage and delayed gastric empting, if present, was classified according to the International Group Study Pancreatic Surgery (IGSPS) classification (14,15), hospital stay and readmissions. The histological data retrieved were TNM: tumor size and lymph nodes harvested and R status. Postoperative follow-up (months) including endocrine and exocrine insufficiency rate.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Any distal pancreatectomy (DP) with multivisceral resection (MVR) defining MVR as any organ different from distal pancreas or spleen

排除标准

  • Distal Pancreatectomy with celiac trunk resection (Appleby procedure) or portal vein resection.

结局指标

主要结局

Mortality

时间窗: 90 days

If the patient dies in the postoperative period

Morbidity

时间窗: 90 days

Any complication in the postoperative period

次要结局

未报告次要终点

研究者

发起方
Universidad de Extremadura
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gerardo Blanco-Fernández

Chief of department

Universidad de Extremadura

研究点 (1)

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