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

Recruiting

• Conditions: Hepato-Biliary Precancerous Condition

• Registration Number: NCT05703139
• Lead Sponsor: Sohag University

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2023-01-16
• Study First Submitted QC: 2023-01-26
• Study First Posted: 2023-01-27
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Study Start: 2023-11-21
• Last Update Posted: 2023-11-21
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Read More

Exclusion Criteria

• Unfit or inoperable patients will be excluded.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).

Trial Locations

Locations (1)

Sohag University; 🇪🇬 Sohag, Nasser City, Egypt