Conventional Partial Pancreatoduodenectomy Versus an Extended Pancreatoduodenectomy for Pancreatic Head Cancers

NCT06703905 | Not Yet Recruiting

• 1 other identifier: ZXIIT2024180
• Study Type: interventional
• Target: 270
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pancreatic Cancer Resectable

Keywords

Pancreatic cancer; pancreaticoduodenectomy; Minimally invasive surgery; Heidelberg Triangle

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• the rate of microscopically complete margin clearance

  Intraoperative

• the rate of microscopic margin clearance ≤ 0.1 cm

  Intraoperative

• the rate of microscopic margin involvement (R1) resections

  Intraoperative

• the rate of postoperative pancreatic fistula

  Day of discharge, postoperative days 5, 10-12 and 90

• the rate of postpancreatectomy haemorrhage

  Day of discharge, postoperative days 5, 10-12 and 90

Other Outcomes (7)

• Overall survival

  3, 6, 12, 18, 24, 30, 36 months after surgery (or early termination of the trial)

• 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)

  Screening, Day of discharge, and 6, 12, 18, 24, 30, 36 months after surgery

Study Arms (2)

PD group

ACTIVE COMPARATOR

Traditional minimally invasive pancreaticoduodenectomy

Procedure: Pancreaticoduodenectomy

expanded PD group

EXPERIMENTAL

Traditional minimally invasive pancreaticoduodenectomy combined with the TRIANGLE procedure

Procedure: Expanded pancreaticoduodenectomy surgery

Interventions

Expanded pancreaticoduodenectomy surgery PROCEDURE

Traditional minimally invasive pancreaticoduodenectomy combined with the TRIANGLE procedure

expanded PD group

Pancreaticoduodenectomy PROCEDURE

Traditional minimally invasive pancreaticoduodenectomy

PD group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Pancreaticoduodenectomy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Zheng Wang, Doctor

CONTACT

86+15902993665; zheng.wang11@mail.xjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 25, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 25, 2024

Record last verified: 2024-11