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

NCT03224832 | Unknown

• 1 other identifier: mas2017
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periampullary Carcinoma Resectable

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• - 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

Study Arms (2)

group 1

EXPERIMENTAL

group 1 will be Pancreatoduodenectomy With Mesopancreas. Artery-first Approach

Procedure: Artery-first Approach

group2

EXPERIMENTAL

group2 will be Pancreatoduodenectomy With Mesopancreas Dissection. Standard Approach

Procedure: Standard Approach

Interventions

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. * 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.

Also known as: group 1

group 1

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.

Also known as: group2

group2

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All cases of resectable periampullary carcinoma
• surgically fit accordying to ASA

You may not qualify if:

• Surgically unfit cases according to ASA.
• locally advanced irresectable cases

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related 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.

  PMID: 22264964 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.

  PMID: 8104092 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.

  PMID: 17459163 RESULT

Related 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).

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer at General surgery department

Model Details: 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

Study Record Dates

• First Submitted: July 13, 2017
• First Posted: July 21, 2017
• Study Start: August 1, 2017
• Primary Completion: July 1, 2019
• Study Completion: January 1, 2020
• Last Updated: August 10, 2017

Record last verified: 2017-05

Locations

EG (1)