Clinical trial NCT06703905: Conventional Partial Pancreatoduodenectomy Versus an Extended Pancreatoduodenectomy for Pancreatic Head Cancers
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pancreatic Cancer Resectable
Keywords: Pancreatic cancer
pancreaticoduodenectomy
Minimally invasive surgery
Heidelberg Triangle
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2024-11-25
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Preoperative: a. Patients with suspected or histologically verified resectable, borderline or locally advanced pancreatic cancer of the pancreatic head (i.e. pancreatic ductal adenocarcinoma, intraductal papillary mucinous neoplasm (IPMN)-carcinoma or periampullary cancer of the pancreatobiliary-type) ; b. Patients scheduled for elective partial pancreatoduodenectomy (irrespective of neoadjuvant therapy); c. Assumed resectability in accordance with the surgical protocol for experimental and control intervention as judged by the treating surgeon; d. Ability of the subject to understand character and individual consequences of the clinical trial;e.Written informed consent; f. Age ≥ 18 years;
2. Intraoperative: a.No distant metastases; b.No paraaortic lymph node metastases; c.Intraoperative confirmation that the patient can be operated on according to both surgical methods.

Exclusion Criteria:

1. Participation in another interventional trial with the interference of intervention and outcome of this trial;
2. American Society of Anesthesiologists (ASA) grade \>3;
3. Distant metastatic disease .

Primary outcomes:
measure: Disease-free survival after resection
timeFrame: 3, 6, 12, 18, 24, 30, 36 months after surgery (or early termination of the trial)
Secondary outcomes:
measure: the rate of microscopically complete margin clearance
timeFrame: Intraoperative
measure: the rate of microscopic margin clearance ≤ 0.1 cm
timeFrame: Intraoperative
measure: the rate of microscopic margin involvement (R1) resections
timeFrame: Intraoperative
measure: the rate of postoperative pancreatic fistula
timeFrame: Day of discharge, postoperative days 5, 10-12 and 90
measure: the rate of postpancreatectomy haemorrhage
timeFrame: Day of discharge, postoperative days 5, 10-12 and 90
measure: the rate of delayed gastric emptying
timeFrame: Day of discharge, postoperative days 5, 10-12 and 90
measure: the rate of bile leakage
timeFrame: Day of discharge, postoperative days 5, 10-12 and 90
measure: the rate of lymphatic fistula
timeFrame: Day of discharge, postoperative days 5, 10-12 and 90
measure: the rate of diarrhoea
timeFrame: Day of discharge, postoperative days 5, 10-12 and 90
Other outcomes:
measure: Overall survival
timeFrame: 3, 6, 12, 18, 24, 30, 36 months after surgery (or early termination of the trial)
measure: Quality of Life questionnaire (QLQ-C30)
timeFrame: Screening, Day of discharge, and 6, 12, 18, 24, 30, 36 months after surgery
measure: pancreatic cancer specific questionnaire (PAN26)
timeFrame: Screening, Day of discharge, and 6, 12, 18, 24, 30, 36 months after surgery
measure: Local recurrence within the study period
timeFrame: 3, 6, 12, 18, 24, 30, 36 months after surgery (or early termination of the trial)
measure: Length of primary hospital stay in days
timeFrame: Day of discharge
measure: Quality of recovery
timeFrame: Screening, postoperative days 5
measure: Serious adverse events
timeFrame: 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)
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