Pancreatic CancerPROBNCT06541340
A New Strategy for Preoperative Drainage of Resectable Pancreatic Head Cancer Combined Severe Obstructive Jaundice
A study testing Modified strategy and Traditional strategy in people with Pancreatic Cancer and Obstructive Jaundice, run by Ruijin Hospital at 1 site in China.
Trial summary
Severe obstructive jaundice caused by pancreatic head cancer usually requires preoperative biliary drainage, but its necessity and effectiveness are controversial, and specific strategies lack clear standards. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer, Obstructive Jaundice
- What is being tested?
- Modified strategy and Traditional strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 31 Dec 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathological diagnosis of pancreatic head cancer, or clinical diagnosis of pancreatic head cancer after multidisciplinary discussion, clear presence of obstructive jaundice caused by pancreatic head tumor, and planned to undergo radical pancreaticoduodenectomy
- Preoperative imaging stage is resectable
- Baseline serum total bilirubin ≥ 250μmol/L, and no history of preoperative biliary drainage
- Age >18 and ≤75 years old
- ECOG(Eastern Cooperative Oncology Group) physical score ≤ 2
- Signed informed consent, received preoperative endoscopic biliary drainage (ERCP) and radical surgery timing evaluation
Who cannot join
- Combined with other malignant tumors
- Combined with uncontrolled medical diseases or organ dysfunction and other absolute counterindications for surgery
- Pregnant and lactating women
- Patients who cannot tolerate preoperative biliary drainage or radical surgery
- Other situations that are not suitable for inclusion in clinical trials
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Baiyong Shen, Ph.D&M.D, 0086-021-64370045
Baiyong Shen, Ph.D&M.D
About this study
Official title: A New Strategy for Preoperative Drainage of Resectable Pancreatic Head Cancer Combined Severe Obstructive Jaundice, a Multicenter, Open-label, Randomized Controlled Clinical Study
Severe obstructive jaundice caused by pancreatic head cancer usually requires preoperative biliary drainage, but its necessity and effectiveness are controversial, and specific strategies lack clear standards. This study proposed a new strategy for preoperative biliary drainage using serum prealbumin as the main evaluation index, and compared it with the traditional strategy using serum total bilirubin as the main evaluation index. Through a randomized, controlled, multicenter prospective study, we explored the effects of different drainage strategies on the incidence of in-hospital complications and long-term prognosis of patients with resectable pancreatic head cancer, guided clinical decisions on preoperative drainage time and surgical timing, and provided high-quality evidence-based medicine for preoperative biliary drainage of pancreatic head cancer.
- Conditions
- Pancreatic Cancer, Obstructive Jaundice
- Being tested
- Modified strategy, Traditional strategy
- Keywords
- pancreatic head cancer, obstructive Jaundice, preoperative biliary drainage, prealbumin
- Medical subject headings
- Pancreatic Neoplasms, Jaundice, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified strategyProcedure or surgery
Modified preoperative biliary drainage strategy with prealbumin as the main indicator
Traditional strategyProcedure or surgery
Traditional preoperative biliary drainage strategy with total bilirubin as the main indicator
| Study group | Role | What they receive |
|---|---|---|
| Traditional strategy | Active comparator | Traditional preoperative biliary drainage strategy with total bilirubin as the main indicator Receives: Procedure: Traditional strategy |
| Modified strategy | Experimental | Modified preoperative biliary drainage strategy with prealbumin as the main indicator Receives: Procedure: Modified strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital complications
In-hospital complications are comprehensively evaluated by the chief surgeon, responsible doctor and their team based on clinical manifestations, laboratory tests, etc., and reviewed by the expert committee of this study. The name of the complication, time of occurrence, treatment measures and outcome are strictly recorded.
Measured: During hospitalization, up tp 3 months
Secondary outcomes (3)
Recurrence/metastasis
It is mainly based on follow-up. If the follow-up was completed in our hospital, the hospital system will be directly retrieved to obtain the diagnosis information. The follow-up was conducted by interviewing the patient or his family members through telephone questionnaires or face-to-face visits to collect required information.The follow-up subjects provide medical records, etc., and record in detail the time of diagnosis of long-term complications or recurrence and metastasis, diagnostic basis, laboratory tests, treatment measures and outcomes, which must be reviewed by the expert committee of this study.
Measured: 12 months after discharge
Mortality
It is mainly based on follow-up. If the follow-up was completed in our hospital, the hospital system will be directly retrieved to obtain the diagnosis information. The follow-up was conducted by interviewing the patient or his family members through telephone questionnaires or face-to-face visits to collect required information.The follow-up subjects provide medical records, etc., and record in detail the time of diagnosis of long-term complications or recurrence and metastasis, diagnostic basis, laboratory tests, treatment measures and outcomes, which must be reviewed by the expert committee of this study.
Measured: 12 months after discharge
Long-term complications
It is mainly based on follow-up. If the follow-up was completed in our hospital, the hospital system will be directly retrieved to obtain the diagnosis information. The follow-up was conducted by interviewing the patient or his family members through telephone questionnaires or face-to-face visits to collect required information.The follow-up subjects provide medical records, etc., and record in detail the time of diagnosis of long-term complications or recurrence and metastasis, diagnostic basis, laboratory tests, treatment measures and outcomes, which must be reviewed by the expert committee of this study.
Measured: 12 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start1 Aug 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541340
- Sponsor's protocol ID
- PROB
- Acronym
- PROB
- Status last verified
- Jul 2024
- First submitted
- 30 Jul 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Strategy for Preoperative Drainage of Resectable Pancreatic Head Cancer Combined Severe Obstructive Jaundice, a Multicenter, Open-label, Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT06541340
- Acronym / sponsor ID
- PROB / PROB
- Conditions
- Pancreatic Cancer, Obstructive Jaundice
- Keywords
- pancreatic head cancer, obstructive Jaundice, preoperative biliary drainage, prealbumin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Aug 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.
Severe obstructive jaundice caused by pancreatic head cancer usually requires preoperative biliary drainage, but its necessity and effectiveness are controversial, and specific strategies lack clear standards. This study proposed a new strategy for preoperative biliary drainage using serum prealbumin as the main evaluation index, and compared it with the traditional strategy using serum total bilirubin as the main evaluation index. Through a randomized, controlled, multicenter prospective study, we explored the effects of different drainage strategies on the incidence of in-hospital complications and long-term prognosis of patients with resectable pancreatic head cancer, guided clinical decisions on preoperative drainage time and surgical timing, and provided high-quality evidence-based medicine for preoperative biliary drainage of pancreatic head cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional strategy | Active comparator | Procedure: Traditional strategyTraditional preoperative biliary drainage strategy with total bilirubin as the main indicator |
| Modified strategy | Experimental | Procedure: Modified strategyModified preoperative biliary drainage strategy with prealbumin as the main indicator |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pathological diagnosis of pancreatic head cancer, or clinical diagnosis of pancreatic head cancer after multidisciplinary discussion, clear presence of obstructive jaundice caused by pancreatic head tumor, and planned to undergo radical pancreaticoduodenectomy
- Preoperative imaging stage is resectable
- Baseline serum total bilirubin ≥ 250μmol/L, and no history of preoperative biliary drainage
- Age >18 and ≤75 years old
- ECOG(Eastern Cooperative Oncology Group) physical score ≤ 2
Key exclusion criteria (5 listed)
- Combined with other malignant tumors
- Combined with uncontrolled medical diseases or organ dysfunction and other absolute counterindications for surgery
- Pregnant and lactating women
- Patients who cannot tolerate preoperative biliary drainage or radical surgery
- Other situations that are not suitable for inclusion in clinical trials
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 |
|---|---|---|
| Modified strategyModified preoperative biliary drainage strategy with prealbumin as the main indicator | Procedure or surgery | Modified strategy |
| Traditional strategyTraditional preoperative biliary drainage strategy with total bilirubin as the main indicator | Procedure or surgery | Traditional strategy |
Primary outcome
In-hospital complications
Time frame: During hospitalization, up tp 3 months
In-hospital complications are comprehensively evaluated by the chief surgeon, responsible doctor and their team based on clinical manifestations, laboratory tests, etc., and reviewed by the expert committee of this study. The name of the complication, time of occurrence, treatment measures and outcome are strictly recorded.
3 secondary outcomes
Recurrence/metastasis
Time frame: 12 months after discharge
Mortality
Time frame: 12 months after discharge
Long-term complications
Time frame: 12 months after discharge
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 7 Aug 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified strategy and Traditional strategy in people with Pancreatic Cancer and Obstructive Jaundice, run by Ruijin Hospital at 1 site in China.
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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Jun Zhang, Ph.D&M.D (+86 18917530547, zj11477@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital complications (time frame: During hospitalization, up tp 3 months). 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 7 Aug 2024.