Pancreatic Exocrine InsufficiencyPhase 4NCT06119880
The Effect of PERT on Patients Undergoing Pancreaticoduodenectomy
A Phase 4 study testing Pancreatin Enteric-coated Capsules and Routine treatment plan in people with Pancreatic Exocrine Insufficiency and Pancreatic Enzyme Replacement Therapy, run by Ruijin Hospital at 1 site in China.
Trial summary
A comprehensive perioperative nutrition management plan for pancreaticoduodenectomy, primarily based on pancreatic enzyme replacement therapy (PERT). A prospective randomized controlled study was conducted to comprehensively analyze the perioperative nutritional status of patients undergoing pancreaticoduodenectomy… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Exocrine Insufficiency, Pancreatic Enzyme Replacement Therapy, Pancreaticoduodenectomy
- What is being tested?
- Pancreatin Enteric-coated Capsules and Routine treatment plan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gender unlimited, 18-80 years old;
- Patients undergoing pancreaticoduodenectomy due to various benign or malignant diseases;
- Voluntary testing with informed consent.
Who cannot join
- Pregnant women and lactating women
- Patients with distant metastasis based on tumor staging before surgery;
- Tumor recurrence;
- Refuse to sign the consent form.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Weishen WANG, 0086-(0)21-64370045 ext. 362362, peanutswey@hotmail.com
About this study
Official title: The Effect of PERT on Postoperative Complications and Physiological Status in Patients Undergoing Pancreaticoduodenectomy
A comprehensive perioperative nutrition management plan for pancreaticoduodenectomy, primarily based on pancreatic enzyme replacement therapy (PERT). A prospective randomized controlled study was conducted to comprehensively analyze the perioperative nutritional status of patients undergoing pancreaticoduodenectomy, with the aim of exploring:
- The effect of PERT on postoperative complications and physiological status after pancreaticoduodenectomy;
- The efficacy of PERT treatment on clinical symptoms, nutritional indicators, and quality of life (QOL) related to pancreatic exocrine dysfunction (PEI) after pancreaticoduodenectomy;
- The personalized full process nutrition management strategies based on risk factor stratification.
- Conditions
- Pancreatic Exocrine Insufficiency, Pancreatic Enzyme Replacement Therapy, Pancreaticoduodenectomy
- Being tested
- Pancreatin Enteric-coated Capsules, Routine treatment plan
- Medical subject headings
- Exocrine Pancreatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreatin Enteric-coated CapsulesDrug
pancreatic enzyme replacement therapy
Routine treatment planOther
Routine treatment plan without PERT
| Study group | Role | What they receive |
|---|---|---|
| PERT Group | Experimental | After surgery, resume diet and begin receiving standard PERT treatment (2 capsules per meal, 1 capsule per snack, taken with meals, starting at a dose of 40000 to 50000 units of lipase) for 8 weeks. Receives: Drug: Pancreatin Enteric-coated Capsules |
| Placebo Group | Placebo comparator | Follow the routine treatment plan for pancreatic tumors during the perioperative period. Receives: Other: Routine treatment plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal Skeletal Muscle Index (SMI)
Measurement of abdominal skeletal muscle area at the third lumbar spine plane using abdominal plain scan CT and comparison of baseline level SMI change rate.
Measured: 8 weeks post-operation
Secondary outcomes (2)
Postoperative complications
postoperative pancreatic fistula, delayed gastric emptying, postoperative hypoproteinemia;
Measured: 8 weeks post-operation
Nutritional indicators
Patient generated subjective global assessment (PG-SGA);
Measured: 8 weeks post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Nov 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Exocrine InsufficiencyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weishen WANG, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119880
- Sponsor's protocol ID
- HBP-RCT-004
- Status last verified
- Nov 2023
- First submitted
- 25 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of PERT on Postoperative Complications and Physiological Status in Patients Undergoing Pancreaticoduodenectomy
- ClinicalTrials.gov ID
- NCT06119880
- Acronym / sponsor ID
- HBP-RCT-004
- Conditions
- Pancreatic Exocrine Insufficiency, Pancreatic Enzyme Replacement Therapy, Pancreaticoduodenectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Nov 2023 (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.
A comprehensive perioperative nutrition management plan for pancreaticoduodenectomy, primarily based on pancreatic enzyme replacement therapy (PERT). A prospective randomized controlled study was conducted to comprehensively analyze the perioperative nutritional status of patients undergoing pancreaticoduodenectomy, with the aim of exploring:
- The effect of PERT on postoperative complications and physiological status after pancreaticoduodenectomy;
- The efficacy of PERT treatment on clinical symptoms, nutritional indicators, and quality of life (QOL) related to pancreatic exocrine dysfunction (PEI) after pancreaticoduodenectomy;
- The personalized full process nutrition management strategies based on risk factor stratification.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PERT Group | Experimental | Drug: Pancreatin Enteric-coated CapsulesAfter surgery, resume diet and begin receiving standard PERT treatment (2 capsules per meal, 1 capsule per snack, taken with meals, starting at a dose of 40000 to 50000 units of lipase) for 8 weeks. |
| Placebo Group | Placebo comparator | Other: Routine treatment planFollow the routine treatment plan for pancreatic tumors during the perioperative period. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Gender unlimited, 18-80 years old;
- Patients undergoing pancreaticoduodenectomy due to various benign or malignant diseases;
- Voluntary testing with informed consent.
Key exclusion criteria (4 listed)
- Pregnant women and lactating women
- Patients with distant metastasis based on tumor staging before surgery;
- Tumor recurrence;
- Refuse to sign the consent form.
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 |
|---|---|---|
| Pancreatin Enteric-coated Capsulespancreatic enzyme replacement therapy | Drug | PERT Group |
| Routine treatment planRoutine treatment plan without PERT | Other | Placebo Group |
Primary outcome
Abdominal Skeletal Muscle Index (SMI)
Time frame: 8 weeks post-operation
Measurement of abdominal skeletal muscle area at the third lumbar spine plane using abdominal plain scan CT and comparison of baseline level SMI change rate.
2 secondary outcomes
Postoperative complications
Time frame: 8 weeks post-operation
Nutritional indicators
Time frame: 8 weeks post-operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pancreatin Enteric-coated Capsules and Routine treatment plan in people with Pancreatic Exocrine Insufficiency and Pancreatic Enzyme Replacement Therapy, 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 7 Nov 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weishen WANG, DR (64370045, peanutswey@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal Skeletal Muscle Index (SMI) (time frame: 8 weeks post-operation). 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 Nov 2023.