Hepato-Biliary Precancerous ConditionNCT05703139
Efficacy of the Triangle Operation on Clinical Outcomes in Patients With Pancreatic Cancer
An observational study of Hepato-Biliary Precancerous Condition, run by Sohag University at 1 site in Egypt.
Trial summary
We aimed to analyze postoperative short-and long-terms clinical outcomes after the Triangle procedure in patients with Pancreatic head, periampullary and duodenal cancer. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Hepato-Biliary Precancerous Condition
- What is being tested?
- TRIANGLE procedure
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Nov 2023to 30 Jun 2024
- Phase
- Observational
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study includes cases that match our eligibility criteria No age restriction or Gender exclusion, all diagnosed fit patients with pancreatic head, periampullary and duodenal cancer will be included, Unfit or inoperable patients will be excluded.
Who may be able to join
- No age restriction or Gender exclusion, all diagnosed fit patients with pancreatic head, periampullary and duodenal cancer will be included.
Who cannot join
- Unfit or inoperable patients will be excluded.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University
Sohag, Nasser City, 82516
hossam abd ellatif mohamed, assistant l, 01094075956 ext. 002, kirkar2009@yahoo.com
About this study
We aimed to analyze postoperative short-and long-terms clinical outcomes after the Triangle procedure in patients with Pancreatic head, periampullary and duodenal cancer.
Read the detailed description
After laparotomy and exploration of the abdominal cavity to rule out peritoneal or hepatic metastases, the initial steps of the operation were to determine if there was true arterial tumor infiltration, along the Celiac Artery, Hepatic Artery or Superior Mesenteric Artery. To clarify this, an "arteryfirst" maneuver was performed. The strategy depended on the results of preoperative imaging defining the site of the most likely tumor infiltration. The SMA was approached from a left-sided infracolic approach if tumors of the body or tail of the pancreas were suspected to infiltrate the artery from this direction or from a posterior approach in respective situations. Once the arterial level of suspected attachment/encasement was reached, a frozen section was performed to confirm or exclude viable tumor tissue at this site. In case of remaining viable tumor, most patients will not qualify for further surgical therapy at this point. In contrast, if frozen section confirms fibrous tissue without viable tumor, this offers the possibility to perform a radical but artery-sparing procedure, All other surgical steps are carried out as usual during partial pancreatoduodenectomy (PD), distal (DP) or total pancreatectomy. Anatomic TRIANGLE bordered by the SMA, CA and PV confirming the complete removal of all soft tissue usually contained within these borders.
- Conditions
- Hepato-Biliary Precancerous Condition
- Being tested
- TRIANGLE procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRIANGLE procedureProcedure or surgery
The Triangle procedure aims to develop a novel method for patients with locally advanced pancreatic cancer after neoadjuvant therapy and was described in 2017. The basis of this operation is the notice that after neoadjuvant therapy conventional imaging fails to differentiate between actual tumor encasement and only fibrotic residual tissue mainly to the arterial structures
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the Triangle operation on clinical outcomes in patients with Pancreatic Cancer Efficacy of the Triangle operation on clinical outcomes in patients with Pancreatic Cancer
no recurrence observed
Measured: 6 months
Secondary outcomes (1)
Efficacy of the Triangle operation on clinical outcomes in patients with Pancreatic Cancer
This study aims to evaluate postoperative short- and long-terms clinical outcomes after the Triangle procedure in patients with pancreatic head, periampullary and duodenal cancers.
Operative time will be defined from the time of incision to the closure of the skin.
Short-term outcome starts from the date of surgery until date of discharge those post-operative complications will be categorized according to the Clavien-Dindo Grading System (Dindo et al., 2004).
Post-operative pancreatic fistula (POPF) will be defined according to the International Study Group on Pancreatic Fistula (ISGPF) (Bassi et al., 2005).
Post-operative bile leakage will be defined according to the international study group of liver surgery (ISGLS) (Koch et al., 2011).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start21 Nov 2023 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepato-Biliary Precancerous ConditionStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Abdellatif Mohamed, Sohag University
- Investigators
- asem al mohamed, professor, Study director, Sohag Universityomar ab sayed, professor, Study chair, Sohag Universityemad al ahmed, lecturer, Study chair, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05703139
- Sponsor's protocol ID
- Soh-Med-23-01-15
- Status last verified
- Nov 2023
- First submitted
- 16 Jan 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Triangle Operation on Clinical Outcomes in Patients With Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT05703139
- Acronym / sponsor ID
- Soh-Med-23-01-15
- Conditions
- Hepato-Biliary Precancerous Condition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 21 Nov 2023 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 27 Jan 2023 (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.
We aimed to analyze postoperative short-and long-terms clinical outcomes after the Triangle procedure in patients with Pancreatic head, periampullary and duodenal cancer.
Detailed description
After laparotomy and exploration of the abdominal cavity to rule out peritoneal or hepatic metastases, the initial steps of the operation were to determine if there was true arterial tumor infiltration, along the Celiac Artery, Hepatic Artery or Superior Mesenteric Artery. To clarify this, an "arteryfirst" maneuver was performed. The strategy depended on the results of preoperative imaging defining the site of the most likely tumor infiltration. The SMA was approached from a left-sided infracolic approach if tumors of the body or tail of the pancreas were suspected to infiltrate the artery from this direction or from a posterior approach in respective situations. Once the arterial level of suspected attachment/encasement was reached, a frozen section was performed to confirm or exclude viable tumor tissue at this site. In case of remaining viable tumor, most patients will not qualify for further surgical therapy at this point. In contrast, if frozen section confirms fibrous tissue without viable tumor, this offers the possibility to perform a radical but artery-sparing procedure, All other surgical steps are carried out as usual during partial pancreatoduodenectomy (PD), distal (DP) or total pancreatectomy. Anatomic TRIANGLE bordered by the SMA, CA and PV confirming the complete removal of all soft tissue usually contained within these borders.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study includes cases that match our eligibility criteria No age restriction or Gender exclusion, all diagnosed fit patients with pancreatic head, periampullary and duodenal cancer will be included, Unfit or inoperable patients will be excluded.
Key inclusion criteria (1 listed)
- No age restriction or Gender exclusion, all diagnosed fit patients with pancreatic head, periampullary and duodenal cancer will be included.
Key exclusion criteria (1 listed)
- Unfit or inoperable patients will be excluded.
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 |
|---|---|---|
| TRIANGLE procedureThe Triangle procedure aims to develop a novel method for patients with locally advanced pancreatic cancer after neoadjuvant therapy and was described in 2017. The basis of this operation is the notice that after neoadjuvant therapy conventional imaging fails to differentiate between actual tumor encasement and only fibrotic residual tissue mainly to the arterial structures | Procedure or surgery | – |
Primary outcome
Efficacy of the Triangle operation on clinical outcomes in patients with Pancreatic Cancer Efficacy of the Triangle operation on clinical outcomes in patients with Pancreatic Cancer
Time frame: 6 months
no recurrence observed
1 secondary outcome
Efficacy of the Triangle operation on clinical outcomes in patients with Pancreatic Cancer
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: Undecided
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.
asem al mohamed, professor study director
Sohag University
omar ab sayed, professor study chair
Sohag University
emad al ahmed, lecturer study chair
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepato-Biliary Precancerous Condition, run by Sohag 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 1 inclusion and 1 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 21 Nov 2023. 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 hossam a mohamed, assisstant l (01118544852 ext. 002, hossam.abouelkasem@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of the Triangle operation on clinical outcomes in patients with Pancreatic Cancer Efficacy of the Triangle operation on clinical outcomes in patients with Pancreatic Cancer (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2023.