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

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.

Study Overview

• Status: Unknown
• Conditions: Periampullary Carcinoma Resectable
• Intervention / Treatment: Procedure: Artery-first Approach; Procedure: Standard Approach

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mostafa Ali Sayed, PHD; Phone Number: 0201095937131; Email: mostafa.ali270927@yahoo.com
• Study Contact Backup: Name: Faculty of Medicine-Assiut University -Assiut-Egypt Faculty of Medicine-Assiut University -Assiut-Egypt; Phone Number: 0201095937131

Study Locations

• Egypt
  • Assiut, Egypt
    • Assiut University
    • Contact: Assiut university; Phone Number: 0201095937131; Email: mostafa.ali270927@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group 1; group 1 will be Pancreatoduodenectomy With Mesopancreas. Artery-first Approach	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.; Other Names: group 1
Experimental: group2; group2 will be Pancreatoduodenectomy With Mesopancreas Dissection. Standard Approach	Procedure: 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.; Other Names: group2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2017
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: July 13, 2017
• First Submitted That Met QC Criteria: July 19, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): August 10, 2017
• Last Update Submitted That Met QC Criteria: August 9, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: mas2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

IPD Plan Description

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No