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

We aimed to analyze postoperative short-and long-terms clinical outcomes after the Triangle procedure in patients with Pancreatic head, periampullary and duodenal cancer.

Study Overview

• Status: Recruiting
• Conditions: Hepato-Biliary Precancerous Condition
• Intervention / Treatment: Procedure: TRIANGLE procedure

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 Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: hossam a mohamed, assisstant l; Phone Number: 002 01118544852; Email: hossam.abouelkasem@med.sohag.edu.eg

Study Locations

• Egypt
  • Nasser City
    • Sohag, Nasser City, Egypt, 82516
      • Recruiting
      • Sohag University
      • Contact: hossam abd ellatif mohamed, assistant l; Phone Number: 002 01094075956; Email: kirkar2009@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	1 year

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Study Director: asem al mohamed, professor, Sohag University; Study Chair: omar ab sayed, professor, Sohag University; Study Chair: emad al ahmed, lecturer, Sohag University

Study record dates

Study Major Dates

• Study Start (Estimated): November 21, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: January 16, 2023
• First Submitted That Met QC Criteria: January 26, 2023
• First Posted (Actual): January 27, 2023

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Precancerous Conditions
• Other Study ID Numbers: Soh-Med-23-01-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No