Pancreatic Cancer ResectableNCT06703905
Conventional Partial Pancreatoduodenectomy Versus an Extended Pancreatoduodenectomy for Pancreatic Head Cancers
A study testing Expanded pancreaticoduodenectomy surgery and Pancreaticoduodenectomy in people with Pancreatic Cancer Resectable, run by First Affiliated Hospital Xi'an Jiaotong University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pancreatic Cancer Resectable
- What is being tested?
- Expanded pancreaticoduodenectomy surgery and Pancreaticoduodenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 .
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Pancreatic Cancer Resectable
- Being tested
- Expanded pancreaticoduodenectomy surgery, Pancreaticoduodenectomy
- Keywords
- Pancreatic cancer, pancreaticoduodenectomy, Minimally invasive surgery, Heidelberg Triangle
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expanded pancreaticoduodenectomy surgeryProcedure or surgery
Traditional minimally invasive pancreaticoduodenectomy combined with the TRIANGLE procedure
PancreaticoduodenectomyProcedure or surgery
Traditional minimally invasive pancreaticoduodenectomy
| Study group | Role | What they receive |
|---|---|---|
| PD group | Active comparator | Traditional minimally invasive pancreaticoduodenectomy Receives: Procedure: Pancreaticoduodenectomy |
| expanded PD group | Experimental | Traditional minimally invasive pancreaticoduodenectomy combined with the TRIANGLE procedure Receives: Procedure: Expanded pancreaticoduodenectomy surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival after resection
the primary outcome was DFS defined "as the time from randomisation until disease recurrence or death from any cause"
Measured: 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
the rate of >0.1 cm margin clearance, R0(CRM-)
Measured: Intraoperative
the rate of microscopic margin clearance ≤ 0.1 cm
rate of R0(CRM+)
Measured: 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
Measured: Intraoperative
the rate of postoperative pancreatic fistula
the POPF was defined by the International Study Group of Pancreatic Surgery (ISGPS)
Measured: Day of discharge, postoperative days 5, 10-12 and 90
the rate of postpancreatectomy haemorrhage
PPH was defined by the ISGPS
Measured: Day of discharge, postoperative days 5, 10-12 and 90
the rate of delayed gastric emptying
DGE was defined by the ISGPS
Measured: 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)
Measured: Day of discharge, postoperative days 5, 10-12 and 90
the rate of lymphatic fistula
Lymphatic fistula was defined by the ISGPS
Measured: 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
Measured: Day of discharge, postoperative days 5, 10-12 and 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study startDec 2024 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer ResectableStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703905
- Sponsor's protocol ID
- ZXIIT2024180
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06703905
- Acronym / sponsor ID
- ZXIIT2024180
- Conditions
- Pancreatic Cancer Resectable
- Keywords
- Pancreatic cancer, pancreaticoduodenectomy, Minimally invasive surgery, Heidelberg Triangle
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 25 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD group | Active comparator | Procedure: PancreaticoduodenectomyTraditional minimally invasive pancreaticoduodenectomy |
| expanded PD group | Experimental | Procedure: Expanded pancreaticoduodenectomy surgeryTraditional minimally invasive pancreaticoduodenectomy combined with the TRIANGLE procedure |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expanded pancreaticoduodenectomy surgeryTraditional minimally invasive pancreaticoduodenectomy combined with the TRIANGLE procedure | Procedure or surgery | expanded PD group |
| PancreaticoduodenectomyTraditional minimally invasive pancreaticoduodenectomy | Procedure or surgery | PD group |
Primary outcome
Disease-free survival after resection
Time frame: 3, 6, 12, 18, 24, 30, 36 months after surgery (or early termination of the trial)
the primary outcome was DFS defined "as the time from randomisation until disease recurrence or death from any cause"
9 secondary outcomes
the rate of microscopically complete margin clearance
Time frame: Intraoperative
the rate of microscopic margin clearance ≤ 0.1 cm
Time frame: Intraoperative
the rate of microscopic margin involvement (R1) resections
Time frame: Intraoperative
the rate of postoperative pancreatic fistula
Time frame: Day of discharge, postoperative days 5, 10-12 and 90
the rate of postpancreatectomy haemorrhage
Time frame: Day of discharge, postoperative days 5, 10-12 and 90
the rate of delayed gastric emptying
Time frame: Day of discharge, postoperative days 5, 10-12 and 90
the rate of bile leakage
Time frame: Day of discharge, postoperative days 5, 10-12 and 90
the rate of lymphatic fistula
Time frame: Day of discharge, postoperative days 5, 10-12 and 90
the rate of diarrhoea
Time frame: Day of discharge, postoperative days 5, 10-12 and 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Expanded pancreaticoduodenectomy surgery and Pancreaticoduodenectomy in people with Pancreatic Cancer Resectable, run by First Affiliated Hospital Xi'an Jiaotong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zheng Wang, Doctor (86+15902993665, zheng.wang11@mail.xjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival after resection (time frame: 3, 6, 12, 18, 24, 30, 36 months after surgery (or early termination of the trial)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.