Selective Extended Dissection in Different Types of Pancreatic Head Cancer: A Retrospective Cohort Study.

Carcinoma, Pancreatic Ductal Clinical Trial

Official title:

Selective Extended Dissection in Different Types of Pancreatic Head Cancer: A Retrospective Cohort Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05723978
• Other study ID #: Panc-2023129
• Status: Completed
• Start date: January 1, 2011
• Est. completion date: December 1, 2022

Study information

• Verified date: January 2023
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Pancreatic ductal adenocarcinoma (PDAC) is a highly malignant tumor with relatively poor survival. Surgery is the first choice for the treatment of patients with early pancreatic cancer. However, the surgical approach and the extent of resection for patients with pancreatic cancer are controversial at present.

The investigators optimized the procedure of standard pancreaticoduodenectomy to selective extended dissection (SED), which is based on the extra-pancreatic nerve plexus (PLX) potentially invaded by tumor. The investigators retrospectively analyzed the clinicopathological data of patients with pancreatic adenocarcinoma who underwent radical surgery in our center from 2011 to 2020. Patients who underwent standard dissection (SD) were matched 2:1 to those who underwent SED using propensity score matching (PSM). The log-rank test and cox regression model were used to analyze survival data. In addition, statistical analyses were performed for the perioperative complications, postoperative pathology and recurrence pattern.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 520
• Est. completion date: December 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 1) Patients diagnosed as resectable pancreatic cancer were pathologically diagnosed as PDAC after surgery.

2) Patients received radical surgery (R0) and had complete photos or videos of the operation.

Exclusion Criteria:

• 1) The operation records as well as related photo or video data could not reflect the surgical approach and the extent of resection.

2) Patients with incomplete clinical, pathological, imaging and follow-up information.

Related Conditions & MeSH terms

• Carcinoma, Pancreatic Ductal
• Head and Neck Neoplasms

Intervention

Procedure:
• Selective extended dissection of pancreaticoduodenectomy
An optimized procedure of pancreaticoduodenectomy which is based on the extra-pancreatic nerve plexus (PLX) potentially invaded by tumor.

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival (DFS)		From the day the patient received surgery to the time the patient was diagnosed with postoperative recurrence, assessed up to 36 months.