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

Sponsor
Sohag University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05703139
Collaborator
(none)
50
1
16.3
3.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Efficacy of the Triangle Operation on Clinical Outcomes in Patients With Pancreatic Cancer
Anticipated Study Start Date :
Feb 20, 2023
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Outcome Measures

Primary Outcome Measures

  1. 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 [6 months]

    no recurrence observed

Secondary Outcome Measures

  1. Efficacy of the Triangle operation on clinical outcomes in patients with Pancreatic Cancer [1 year]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sohag University Sohag Nasser City Egypt 82516

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hossam Abdellatif Mohamed, assistant lecturer, Sohag University
ClinicalTrials.gov Identifier:
NCT05703139
Other Study ID Numbers:
  • Soh-Med-23-01-15
First Posted:
Jan 27, 2023
Last Update Posted:
Jan 27, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 27, 2023