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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD group | Active Comparator | Traditional minimally invasive pancreaticoduodenectomy |
|
| expanded PD group | Experimental | Traditional minimally invasive pancreaticoduodenectomy combined with the TRIANGLE procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Expanded pancreaticoduodenectomy surgery | Procedure | Traditional minimally invasive pancreaticoduodenectomy combined with the TRIANGLE procedure |
|
| 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) |
| 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+) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 3, 6, 12, 18, 24, 30, 36 months after surgery (or early termination of the trial) | |
| Quality of Life questionnaire (QLQ-C30) | Defined according to the European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life questionnaire QLQ-C30 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zheng Wang, Doctor | Contact | 86+15902993665 | zheng.wang11@mail.xjtu.edu.cn |
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| Pancreaticoduodenectomy | Procedure | Traditional minimally invasive pancreaticoduodenectomy |
|
| 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 |
| Screening, Day of discharge, and 6, 12, 18, 24, 30, 36 months after surgery |
| pancreatic cancer specific questionnaire (PAN26) | The European Organisation for Research and Treatment of Cancer (EORTC) pancreatic cancer specific questionnaire (QLQ-PAN26) | Screening, Day of discharge, and 6, 12, 18, 24, 30, 36 months after surgery |
| Local recurrence within the study period | 3, 6, 12, 18, 24, 30, 36 months after surgery (or early termination of the trial) |
| Length of primary hospital stay in days | Length of primary hospital stay in days was from the day of index operation to the day of discharge | Day of discharge |
| Quality of recovery | Defined according to the QoR-15 questionnaire on postoperative day 5 compared to baseline | Screening, postoperative days 5 |
| Serious adverse events | Day of surgery, day of discharge, postoperative days 5, 10-12 and 90, and 6, 12, 18, 24, 30, 36 months after surgery (or early termination of the trial) |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D016577 | Pancreaticoduodenectomy |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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