Pancreatoduodenectomy With Mesopancreas Dissection.A Prospective Study Comparing Artery-first Approach Versus Standard Approach

Periampullary Carcinoma Resectable Clinical Trial

Official title:

Pancreatoduodenectomy With Mesopancreas Dissection.A Prospective Study Comparing Artery-first Approach Versus Standard Approach

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03224832
• Other study ID #: mas2017
• Status: Not yet recruiting
• Phase: N/A
• First received: July 13, 2017
• Last updated: August 9, 2017
• Start date: August 2017
• Est. completion date: January 1, 2020

Study information

• Verified date: May 2017
• Source: Assiut University
• Contact: Mostafa Ali Sayed, PHD
• Phone: 0201095937131
• Email: mostafa.ali270927[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

• 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.

• This allows a complete clearance of retro- pancreatic tissues.

• -En bloc resection of the primary tumor and regional lymph nodes through complete excision of the mesopancreatic plane, utilizing the artery-first approach.

• -The mesopancreatic plane consists of the pancreas head, the uncinate process of the pancreas, and the meso-pancreatoduodenum.

• 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 the investigators 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.

• This can guide the pathologist to identify the retro pancreatic margins and define whenever there is an R1 resection the exact area of invasion. Microscopic margin involvement (R1) will be defined as tumor within 1 mm of resection margin.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 1, 2020
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• All cases of resectable periampullary carcinoma

• surgically fit accordying to ASA

Exclusion Criteria:

• Surgically unfit cases according to ASA.

• locally advanced irresectable cases

Related Conditions & MeSH terms

• Periampullary Carcinoma Resectable

Intervention

Procedure:
• Artery-first Approach
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. The mesopancreatic plane consists of the pancreas head, the uncinate process of the pancreas, and the meso-pancreatoduodenum. 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.
• Standard Approach
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.

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Mortality rate.	number of deaths intraoperative and immediate postoperative	up to 15 months after each case
Secondary	- 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
Secondary	locoregional recurrence	locoregional recurrence follow up ct abdomen every 4 months postoperative till 15 months postoperative	15 month after the last case of the study
Secondary	Postoperative complications	Postoperative complications especially diarrhea	15 month after the last case of the study

External Links

•   Clearance of the retropancreatic margin in pancreatic carcinomas: total mesopancreas excision or extended lymphadenectomy? [Eur J Surg Oncol. 2012]
•   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).
•   The frequency of retroperitoneal recurrence of carcinoma of the head of the pancreas suggests that retroperitoneal resection,