Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-01-09 @ 9:29 PM
Study NCT ID:
NCT06703905
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-25
First Post:
2024-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conventional Partial Pancreatoduodenectomy Versus an Extended Pancreatoduodenectomy for Pancreatic Head Cancers
Sponsor:
First Affiliated Hospital Xi'an Jiaotong University
Organization:
Study Overview
Official Title:
Short and Long-term Outcomes of Minimally Invasive Pancreatoduodenectomy Combined with Triangle Operation for Resectable Pancreatic Cancer: an International Multicenter Randomized Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if traditional pancreaticoduodenectomy (PD) combined with TRIANGLE (extended PD surgery) can increase disease-free survival (DFS) in patients with pancreatic head cancers compared to traditional minimally invasive PD. The main questions it aims to answer are:
* Does extended PD surgery increase disease-free survival (DFS)?
* Does extended PD surgery could improve postoperative and long-term quality of life for patients? Researchers will compare extended PD surgery to traditional PD surgery to see if extended PD surgery could extend the survival time of patients.
Participants will:
* Accept traditional minimally invasive PD surgery or minimally invasive PD combined with TRIANGLE surgery.
* Visit the clinic once every 3 months for checkups and tests.
* Keep a diary of their symptoms.
* Does extended PD surgery increase disease-free survival (DFS)?
* Does extended PD surgery could improve postoperative and long-term quality of life for patients? Researchers will compare extended PD surgery to traditional PD surgery to see if extended PD surgery could extend the survival time of patients.
Participants will:
* Accept traditional minimally invasive PD surgery or minimally invasive PD combined with TRIANGLE surgery.
* Visit the clinic once every 3 months for checkups and tests.
* Keep a diary of their symptoms.
Detailed Description:
Pancreaticoduodenectomy (PD) currently stands as the sole option for treating resectable pancreatic head cancer; however, the long-term post-operative survival quality of patients remains unpromising. According to statistics from international multicenter studies, the 5-year survival rate of patients post-surgery does not exceed 20%. The principal causes for the suboptimal survival quality are the high recurrence and metastasis tendencies of pancreatic cancer, along with its low sensitivity and poor response to the existing neoadjuvant therapy. In contrast to traditional PD, PD combined with the TRIANGLE procedure (expanded PD) enables more thorough resection, effectively addressing the early recurrence and metastasis issues of pancreatic cancer and holds significant potential in enhancing patients' long-term survival quality. Nevertheless, there exists no high-level clinical evidence regarding the improvement of short-term complications for this surgical approach. Simultaneously, minimally invasive pancreatic surgeries have been demonstrated in high-throughput pancreatic centers to improve patients' short-term quality of life, yet the effect on long-term prognosis remains ambiguous. Hence, our center innovatively proposes minimally invasive PD in combination with the TRIANGLE procedure for the treatment of resectable pancreatic cancer, with the aim of integrating the advantages of both intervention measures to improve patients' post-operative quality of life and long-term survival quality.
This research will carry out a randomized controlled trial on patients with resectable pancreatic cancer who are scheduled to undergo minimally invasive PD in six Chinese centers and two foreign centers, comparing the prognostic disparities between traditional PD and the expanded PD procedure. The primary outcome measure is the postoperative disease-free survival (DFS), defined as "the time from randomization to disease recurrence or death for any reason." The projected enrollment period is 15 months, and the follow-up duration is 3 years.
This research will carry out a randomized controlled trial on patients with resectable pancreatic cancer who are scheduled to undergo minimally invasive PD in six Chinese centers and two foreign centers, comparing the prognostic disparities between traditional PD and the expanded PD procedure. The primary outcome measure is the postoperative disease-free survival (DFS), defined as "the time from randomization to disease recurrence or death for any reason." The projected enrollment period is 15 months, and the follow-up duration is 3 years.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: