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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05703139
Enrollment
50
Registered
2023-01-27
Start date
2023-11-21
Completion date
2024-06-30
Last updated
2023-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepato-Biliary Precancerous Condition

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.

Interventions

PROCEDURETRIANGLE procedure

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

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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 Cancer6 monthsno recurrence observed

Secondary

MeasureTime frameDescription
Efficacy of the Triangle operation on clinical outcomes in patients with Pancreatic Cancer1 yearThis 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).

Countries

Egypt

Contacts

Primary Contacthossam a mohamed, assisstant l
hossam.abouelkasem@med.sohag.edu.eg01118544852

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026