Periampullary Carcinoma ResectableNCT03224832
Pancreatoduodenectomy With Mesopancreas Dissection.A Prospective Study Comparing Artery-first Approach Versus Standard Approach
A study testing Artery-first Approach and Standard Approach in people with Periampullary Carcinoma Resectable, run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Periampullary Carcinoma Resectable
- What is being tested?
- Artery-first Approach and Standard Approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2017to 1 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All cases of resectable periampullary carcinoma
- surgically fit accordying to ASA
Who cannot join
- Surgically unfit cases according to ASA.
- locally advanced irresectable cases
Trial locations and contacts
1 site in 1 country.
Faculty of Medicine-Assiut University -Assiut-Egypt Faculty of Medicine-Assiut University -Assiut-Egypt contact
Egypt1 site
Assiut University
Asyut
Assiut university, 0201095937131, mostafa.ali270927@yahoo.com
About this study
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.
Read more
- 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.
Read the 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.
- Conditions
- Periampullary Carcinoma Resectable
- Being tested
- Artery-first Approach, Standard Approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artery-first ApproachProcedure or surgery
Also called group 1
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 ApproachProcedure or surgery
Also called group2
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.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | group 1 will be Pancreatoduodenectomy With Mesopancreas. Artery-first Approach Receives: Procedure: Artery-first Approach |
| group2 | Experimental | group2 will be Pancreatoduodenectomy With Mesopancreas Dissection. Standard Approach Receives: Procedure: Standard Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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.
Measured: up to 2 weeks postoperative data will be available
Mortality rate.
number of deaths intraoperative and immediate postoperative
Measured: up to 15 months after each case
Secondary outcomes (3)
- 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
Measured: 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
Measured: 15 month after the last case of the study
Postoperative complications
Postoperative complications especially diarrhea
Measured: 15 month after the last case of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study startAug 2017 (estimated)
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Periampullary Carcinoma ResectableStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moustafa Ali Sayed Mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03224832
- Sponsor's protocol ID
- mas2017
- Status last verified
- May 2017
- First submitted
- 13 Jul 2017
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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
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.
PubMed 22264964Kayahara 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.
PubMed 8104092Gockel 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.
PubMed 17459163
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancreatoduodenectomy With Mesopancreas Dissection.A Prospective Study Comparing Artery-first Approach Versus Standard Approach
- ClinicalTrials.gov ID
- NCT03224832
- Acronym / sponsor ID
- mas2017
- Conditions
- Periampullary Carcinoma Resectable
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2017 (estimated)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Procedure: Artery-first Approachgroup 1 will be Pancreatoduodenectomy With Mesopancreas. Artery-first Approach |
| group2 | Experimental | Procedure: Standard Approachgroup2 will be Pancreatoduodenectomy With Mesopancreas Dissection. Standard Approach |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All cases of resectable periampullary carcinoma
- surgically fit accordying to ASA
Key exclusion criteria (2 listed)
- Surgically unfit cases according to ASA.
- locally advanced irresectable cases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artery-first ApproachAlso: group 1Dissection 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. | Procedure or surgery | group 1 |
| Standard ApproachAlso: group2In 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. | Procedure or surgery | group2 |
Primary outcome
Time to judge resectability intra operative and operative time for each procedure.
Time frame: 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.
Time frame: 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)
Pathological data
Time frame: 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.
Time frame: up to 15 months after each case
number of deaths intraoperative and immediate postoperative
3 secondary outcomes
- Short term postoperative survival 15 month after the last case of the study
Time frame: 15 month after the last case of the study
locoregional recurrence
Time frame: 15 month after the last case of the study
Postoperative complications
Time frame: 15 month after the last case of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
- Results publication: PubMed 22264964Adham 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.
- Results publication: PubMed 8104092Kayahara 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.
- Results publication: PubMed 17459163Gockel 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.
- Clearance of the retropancreatic margin in pancreatic carcinomas: total mesopancreas excision or extended lymphadenectomy? \[Eur J Surg Oncol. 2012\]Link provided by the sponsor.
- The frequency of retroperitoneal recurrence of carcinoma of the head of the pancreas suggests that retroperitoneal resection,Link provided by the sponsor.
- 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).Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faculty of Medicine-Assiut University -Assiut-Egypt Faculty of Medicine-Assiut University -Assiut-Egypt contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artery-first Approach and Standard Approach in people with Periampullary Carcinoma Resectable, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mostafa Ali Sayed, PHD (0201095937131, mostafa.ali270927@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to judge resectability intra operative and operative time for each procedure. (time frame: up to 2 weeks postoperative data will be available). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03224832, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2017.