Efficacy of the Triangle Operation on Clinical Outcomes in Patients With Pancreatic Cancer

Trial Title: Efficacy of the Triangle Operation on Clinical Outcomes in Patients With Pancreatic Cancer

NCT ID: NCT05703139

Condition: Hepato-Biliary Precancerous Condition

Conditions: Official terms:
Precancerous Conditions

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Other

Intervention:

Intervention type: Procedure
Intervention name: TRIANGLE procedure
Description: 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

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.

Criteria for eligibility:

Study pop:
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.

Sampling method: Non-Probability Sample
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.

Gender: All

Minimum age: 35 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Sohag University

Address:
City: Sohag
Zip: 82516
Country: Egypt

Status: Recruiting

Contact:
Last name: hossam abd ellatif mohamed, assistant l

Phone: 01094075956

Phone ext: 002
Email: kirkar2009@yahoo.com

Start date: November 21, 2023

Completion date: June 30, 2024

Lead sponsor:
Agency: Sohag University
Agency class: Other

Source: Sohag University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05703139