Clinical trial NCT05703139: Efficacy of the Triangle Operation on Clinical Outcomes in Patients With Pancreatic Cancer
Official title: Efficacy of the Triangle Operation on Clinical Outcomes in Patients With Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepato-Biliary Precancerous Condition
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 50
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* No age restriction or Gender exclusion, all diagnosed fit patients with pancreatic head, periampullary and duodenal cancer will be included.

Exclusion Criteria:

* Unfit or inoperable patients will be excluded.

Primary outcomes:
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
timeFrame: 6 months
Secondary outcomes:
measure: Efficacy of the Triangle operation on clinical outcomes in patients with Pancreatic Cancer
timeFrame: 1 year
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
state: Nasser City
Study officials:
affiliation: Sohag University
name: asem al mohamed, professor
role: STUDY_DIRECTOR
affiliation: Sohag University
name: omar ab sayed, professor
role: STUDY_CHAIR
affiliation: Sohag University
name: emad al ahmed, lecturer
role: STUDY_CHAIR
References: