Pancreatoduodenectomy With Mesopancreas Dissection.A Prospective Study Comparing Artery-first Approach Versus Standard Approach
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pathological data
研究概览
简要总结
The definitions for R0 and R1 margin status after resection for pancreatic cancer are controversial.Various studies showed the rate of noncurative resections of 15- 35 % but with modified pathological examination (R1/R2) revealed the rate of R1 resection was higher ranging from 76-85 % .
Verbeke CS etal.
- Whether this discrepancy was caused by incomplete lymphnode dissection, perineural dissection and improper pathological examination was not yet known.
- Perineural invasion was detected in 77 % of specimens of resected pancreatic cancers.
So the researchers emphasized the need of new surgical classification involving mesopancreas. It can be considered as an anatomical space bounded anteriorly by the the posterior surface of the pancreatic neck, posteriorly by the pancreaticoduodenal coalescence fascia, medially by the mesenteric vessels with -nerves, lymphatics and vessels as its contents.
详细描述
A Controlled clinical trial of pancreatoduodenectomy with mesopancreas dissection.A Prospective study comparing artery-first versus standard approach.
- Target population:
-All cases of malignant obstructive jaundice within the above criteria.
-
Sample size:
-
It will be conventional sample size of about 40 cases minimum about 20 case for each group of the both procedures
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Techniques:
-
The procedure at Assiut university hospital consists of artery-first with l dissection at the origin of the superior mesenteric artery and the celiac trunk all along their right side of the vessels versus standard approach.
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This allows a complete clearance of retro- pancreatic tissues.
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-En bloc resection of the primary tumor and regional lymph nodes through complete excision of the mesopancreatic plane, utilizing the artery-first approach.
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-The mesopancreatic plane consists of the pancreas head, the uncinate process of the pancreas, and the meso-pancreatoduodenum.
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All the tissues that lay in this triangular space (SMA down, CT up, and SMV-PV anterior) is cleared.
Then the investigators continue the dissection along the right then anterior surface of the SMV and PV until reaching the dissected posterior surface the neck of the pancreas .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
the cases which will come to general surgery outpatient clinic will be subjected to standard approach while the cases which will come to our EL Rajhi outpatient clinic will be subjected to artery-first approach
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All cases of resectable periampullary carcinoma
- •surgically fit accordying to ASA
排除标准
- •Surgically unfit cases according to ASA.
- •locally advanced irresectable cases
研究组 & 干预措施
group 1
group 1 will be Pancreatoduodenectomy With Mesopancreas. Artery-first Approach
干预措施: Artery-first Approach (Procedure)
group2
group2 will be Pancreatoduodenectomy With Mesopancreas Dissection. Standard Approach
干预措施: Standard Approach (Procedure)
结局指标
主要结局
Pathological data
时间窗: up to 2 weeks postoperative data will be available
( cancer type, grade,LNS number and focus on infiltration of mesopancreas(R0 free margin more than 1 mm R1 +margin or infiltration less than 1mm.
Mortality rate.
时间窗: up to 15 months after each case
number of deaths intraoperative and immediate postoperative
Time to judge resectability intra operative and operative time for each procedure.
时间窗: up to 2 weeks postoperative data will be available
Time to judge resectability intra operative and operative time for each procedure usually lasts from 3 to 12 hours(operative time)
Blood loss in both procedures.
时间窗: up to 2 weeks postoperative data will be available
Blood loss in both procedures in cc usually lasts from 3 to 12 hours(operative time)
次要结局
- - Short term postoperative survival 15 month after the last case of the study(15 month after the last case of the study)
- locoregional recurrence(15 month after the last case of the study)
- Postoperative complications(15 month after the last case of the study)
研究者
Moustafa Ali Sayed Mahmoud
Assistant lecturer at General surgery department
Assiut University