2024-12
2028-12
2028-12
270
NCT06703905
First Affiliated Hospital Xi'an Jiaotong University
First Affiliated Hospital Xi'an Jiaotong University
INTERVENTIONAL
Conventional Partial Pancreatoduodenectomy Versus an Extended Pancreatoduodenectomy for Pancreatic Head Cancers
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2024-11-18 | N/A | 2024-11-21 |
2024-11-21 | N/A | 2024-11-25 |
2024-11-25 | N/A | 2024-11 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: PD group Traditional minimally invasive pancreaticoduodenectomy | PROCEDURE: Expanded pancreaticoduodenectomy surgery
PROCEDURE: Pancreaticoduodenectomy
|
| EXPERIMENTAL: expanded PD group Traditional minimally invasive pancreaticoduodenectomy combined with the TRIANGLE procedure | PROCEDURE: Expanded pancreaticoduodenectomy surgery
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Disease-free survival after resection | the primary outcome was DFS defined "as the time from randomisation until disease recurrence or death from any cause" | 3, 6, 12, 18, 24, 30, 36 months after surgery (or early termination of the trial) |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| the rate of microscopically complete margin clearance | the rate of >0.1 cm margin clearance, R0(CRM-) | Intraoperative |
| the rate of microscopic margin clearance ≤ 0.1 cm | rate of R0(CRM+) | Intraoperative |
| the rate of microscopic margin involvement (R1) resections | the rate of R1 resection, defined according to the 8th edition of the UICC TNM classification | Intraoperative |
| the rate of postoperative pancreatic fistula | the POPF was defined by the International Study Group of Pancreatic Surgery (ISGPS) | Day of discharge, postoperative days 5, 10-12 and 90 |
| the rate of postpancreatectomy haemorrhage | PPH was defined by the ISGPS | Day of discharge, postoperative days 5, 10-12 and 90 |
| the rate of delayed gastric emptying | DGE was defined by the ISGPS | Day of discharge, postoperative days 5, 10-12 and 90 |
| the rate of bile leakage | Bile leakage was defined by the International Study Group of Liver Surgery (ISGLS) | Day of discharge, postoperative days 5, 10-12 and 90 |
| the rate of lymphatic fistula | Lymphatic fistula was defined by the ISGPS | Day of discharge, postoperative days 5, 10-12 and 90 |
| the rate of diarrhoea | Diarrhoea was graded by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | Day of discharge, postoperative days 5, 10-12 and 90 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Zheng Wang, Doctor Phone Number: 86+15902993665 Email: zheng.wang11@mail.xjtu.edu.cn |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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