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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.
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.
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:
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 .
While in standard approach at first kocharization of the duodenum ,then starting to asses the tunnel under the neck of the pancreas whether tumor infilterating PV/SMV axis and if not the investigators cut the neck of pancreas early in the procedure then continue to dissect the uncinate process and control pancreatoduodenal vessels and draining lymph nodes and LNS around portal vein and up to hepatic artery and we will add to the standard procedure the previously defined mesopancreatic triangle dissection which lies between SMA caudal, Coeliac artery cranial and PV/SMV axis anterior and the specimen will be marked and sent as previous to pathology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1 | Experimental | group 1 will be Pancreatoduodenectomy With Mesopancreas. Artery-first Approach |
|
| group2 | Experimental | group2 will be Pancreatoduodenectomy With Mesopancreas Dissection. Standard Approach |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artery-first Approach | Procedure | Dissection at the origin of the superior mesenteric artery and the celiac trunk all along their right side of the vessels. -En bloc resection of the primary tumor and regional lymph nodes through complete excision of the mesopancreatic plane, utilizing the artery-first approach.
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 . Last step is the division of the neck of the pancreas. After the specimen is removed and before it is sent to the pathology we put mark on each boundary of the specimen one towards SMA, another towards PV/SMV area and the last towards the posterior surface of the mesopancreas. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to judge resectability intra operative and operative time for each procedure. | Time to judge resectability intra operative and operative time for each procedure usually lasts from 3 to 12 hours(operative time) | up to 2 weeks postoperative data will be available |
| Blood loss in both procedures. | Blood loss in both procedures in cc usually lasts from 3 to 12 hours(operative time) | up to 2 weeks postoperative data will be available |
| Pathological data | ( 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. | up to 2 weeks postoperative data will be available |
| Mortality rate. | number of deaths intraoperative and immediate postoperative | up to 15 months after each case |
| Measure | Description | Time Frame |
|---|---|---|
| - Short term postoperative survival 15 month after the last case of the study | - Short term postoperative survival 15 month after the last case of the study | 15 month after the last case of the study |
| locoregional recurrence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mostafa Ali Sayed, PHD | Contact | 0201095937131 | mostafa.ali270927@yahoo.com | |
| Faculty of Medicine-Assiut University -Assiut-Egypt Faculty of Medicine-Assiut University -Assiut-Egypt | Contact | 0201095937131 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut University | Asyut | Egypt |
|
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22264964 | Result | Adham M, Singhirunnusorn J. Surgical technique and results of total mesopancreas excision (TMpE) in pancreatic tumors. Eur J Surg Oncol. 2012 Apr;38(4):340-5. doi: 10.1016/j.ejso.2011.12.015. Epub 2012 Jan 20. | |
| 8104092 | Result | Kayahara M, Nagakawa T, Ueno K, Ohta T, Takeda T, Miyazaki I. An evaluation of radical resection for pancreatic cancer based on the mode of recurrence as determined by autopsy and diagnostic imaging. Cancer. 1993 Oct 1;72(7):2118-23. doi: 10.1002/1097-0142(19931001)72:73.0.co;2-4. |
| Label | URL |
|---|---|
| Clearance of the retropancreatic margin in pancreatic carcinomas: total mesopancreas excision or extended lymphadenectomy? \[Eur J Surg Oncol. 2012\] | View source |
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Prospective comparative study between Artery-first versus standard pancreatoduodenectomy with mesopancreas dissection.
Evaluating perioperative outcomes:Blood loss,Operative time(+/-time to judge resectability),Pathological data(specially those related to mesopancreas) morbidity and mortality
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one group will be subjected to artery fgirst approach at EL Rajhi hospital and the other group will be subjected to standard approach at the main general surgery department at Assiut university hospital
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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
|
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| Standard Approach | Procedure | In standard approach after kocharization of the duodenum the investigators start to asses the tunnel under the neck of the pancreas whether tumor infilterating PV/SMV axis and if not we cut the neck of pancreas early in the procedure then we continue to dissect the uncinate process and control pancreatoduodenal vessels and draining lymph nodes and LNS around portal vein and up to hepatic artery and we will add to the standard procedure the previously defined mesopancreatic triangle dissection which lies between SMA caudal, Coeliac artery cranial and PV/SMV axis anterior and the specimen will be marked and sent as previous to pathology. |
|
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locoregional recurrence follow up ct abdomen every 4 months postoperative till 15 months postoperative
| 15 month after the last case of the study |
| Postoperative complications | Postoperative complications especially diarrhea | 15 month after the last case of the study |
| 17459163 | Result | Gockel I, Domeyer M, Wolloscheck T, Konerding MA, Junginger T. Resection of the mesopancreas (RMP): a new surgical classification of a known anatomical space. World J Surg Oncol. 2007 Apr 25;5:44. doi: 10.1186/1477-7819-5-44. |
| The frequency of retroperitoneal recurrence of carcinoma of the head of the pancreas suggests that retroperitoneal resection, | View source |
| The aim to ensure the greatest possible distance from the retropancreatic lymphatic tissue which drains the carcinomatous focus can be achieved in patients with pancreatic cancer only by complete resection of the mesopancreas (RMP). | View source |