Surgical outcomes in pancreatoduodenectomy- an observational prospective analysis in a tertiary referral cancer center.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Rate and severity of postoperative complications esp. Clavein-Dindo (CD) classification, esp. CD ≥3 rates which includes POPF rates (postoperative pancreatic fistula), DGE rates (delayed gastric emptying), bile leak rates, postoperative hemorrhage rates, and re-exploration rates, SSI (surgical site infection) rates, pulmonary complications rate, cardiac complications rate, and renal complications rate.
研究概览
简要总结
This study is an observational prospective study in which patients undergoing pancreatoduodenectomy surgery (for oncological indications) at a tertiary cancer referral centre in North India, will be followed up along their patient pathway (i.e. first visit à work-up à plan à admission and surgery à discharge and follow-up). The primary outcome measure will be the rate and severity of postoperative complications (refer to part 7). Various secondary outcome measures will be gathered including readmission rate, 30 days and 90 days mortality (refer to part 7). An insight into the various outcome variables can help us gain a perspective, and possibly add to the present evidence and practice.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •All consecutive patients undergoing pancreatoduodenectomy during the study period, with:
- •Age 18 to 80 years
- •ECOG less than 3
- •Patient undergoing pancreatoduodenectomy surgery for cancer involving duodenum, duodenal ampulla, bile duct, and head of pancreas.
排除标准
- •Patients who do not undergo complete resection and pancreatobiliaryenteric reconstruction.
- •Patients who are found to be metastatic on exploration.
结局指标
主要结局
Rate and severity of postoperative complications esp. Clavein-Dindo (CD) classification, esp. CD ≥3 rates which includes POPF rates (postoperative pancreatic fistula), DGE rates (delayed gastric emptying), bile leak rates, postoperative hemorrhage rates, and re-exploration rates, SSI (surgical site infection) rates, pulmonary complications rate, cardiac complications rate, and renal complications rate.
时间窗: 30 days post surgery
次要结局
- Post neoadjuvant exploration rates
- Length of hospital stay/ ICU stay
- 30-day mortality
- 90- day mortality
- Presence and type of preoperative biliary drainage and interval between drainage and surgery.
- Postoperative histopathology stage and site of tumor, pathological diagnosis, Number of lymph nodes dissected, number of positive lymph nodes, lympho-vascular infiltration, perineural infiltration, perivascular infiltration, resection status (R0, R1, R2).
- Positive Intraop Bile culture and sensitivity.
- Re-admission rates(90 days post surgery)
研究者
Dr Mayank Tripathi
Mahamana Pandit Madan Mohan Malaviya Cancer Centre, Varanasi