NCT05723978

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
520

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
11.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
Last Updated

February 13, 2023

Status Verified

January 1, 2023

Enrollment Period

11.5 years

First QC Date

January 31, 2023

Last Update Submit

February 9, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Selective extended dissection (SED) group

Procedure: Selective extended dissection of pancreaticoduodenectomy

Standard dissection (SD) group

Interventions

An optimized procedure of pancreaticoduodenectomy which is based on the extra-pancreatic nerve plexus (PLX) potentially invaded by tumor.

Selective extended dissection (SED) group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed as resectable pancreatic cancer were pathologically diagnosed as PDAC after surgery

You may qualify if:

  • \- 1) Patients diagnosed as resectable pancreatic cancer were pathologically diagnosed as PDAC after surgery.
  • \) Patients received radical surgery (R0) and had complete photos or videos of the operation.

You may not qualify if:

  • \- 1) The operation records as well as related photo or video data could not reflect the surgical approach and the extent of resection.
  • \) Patients with incomplete clinical, pathological, imaging and follow-up information.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 30000, China

Location

Related Publications (1)

  • Guo X, Song Y, Xu P, Zhu W, Wang H, Zhou Y, Huang C, Hao J, Gao S. Selective extended dissection for pancreaticoduodenectomy is associated with better survival in pancreatic cancer patients: retrospective cohort study. Int J Surg. 2023 Jul 1;109(7):1852-1862. doi: 10.1097/JS9.0000000000000437.

MeSH Terms

Conditions

Carcinoma, Pancreatic Ductal

Condition Hierarchy (Ancestors)

Carcinoma, DuctalAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Ductal, Lobular, and MedullaryPancreatic NeoplasmsDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2023

First Posted

February 13, 2023

Study Start

January 1, 2011

Primary Completion

July 1, 2022

Study Completion

December 1, 2022

Last Updated

February 13, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

Locations