Conventional Partial Pancreatoduodenectomy Versus an Extended Pancreatoduodenectomy for Pancreatic Head Cancers

Short and Long-term Outcomes of Minimally Invasive Pancreatoduodenectomy Combined with Triangle Operation for Resectable Pancreatic Cancer: an International Multicenter Randomized Controlled Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Cancer Resectable
• Intervention / Treatment: Procedure: Pancreaticoduodenectomy; Procedure: Expanded pancreaticoduodenectomy surgery

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.

• Study Type: Interventional
• Enrollment (Estimated): 270
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zheng Wang, Doctor; Phone Number: 86+15902993665; Email: zheng.wang11@mail.xjtu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PD group; Traditional minimally invasive pancreaticoduodenectomy	Procedure: Pancreaticoduodenectomy; Traditional minimally invasive pancreaticoduodenectomy
Experimental: expanded PD group; Traditional minimally invasive pancreaticoduodenectomy combined with the TRIANGLE procedure	Procedure: Expanded pancreaticoduodenectomy surgery; Traditional minimally invasive pancreaticoduodenectomy combined with the TRIANGLE procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: November 18, 2024
• First Submitted That Met QC Criteria: November 21, 2024
• First Posted (Estimated): November 25, 2024

Study Record Updates

• Last Update Posted (Estimated): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 21, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: pancreaticoduodenectomy; Pancreatic cancer; Minimally invasive surgery; Heidelberg Triangle
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: ZXIIT2024180

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No