Patients Who Undergo PancreaticoduodenectomyPhase 2NCT07514637
Safety and Efficacy of Anricfen for Postoperative Analgesia and Rehabilitation Promotion After Pancreaticoduodenectomy.Intervention Measures: For Normal Adults, Administer Ariceptin Injection Intravenously Post-operation at a Dose of 1 μg/Kgevery 8 Hours for Three Consecutive Days After Surgery.
A Phase 2 study testing Experimental Group and Anrikefon in people with Patients Who Undergo Pancreaticoduodenectomy, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
Exploring the effectiveness and safety of early use of Ariceptinfen after pancreaticoduodenectomy in alleviating postoperative pain and promoting recovery of patients. Main objective: To explore the analgesic effect of Anricfen after pancreaticoduodenectomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Patients Who Undergo Pancreaticoduodenectomy
- What is being tested?
- Experimental Group and Anrikefon
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 25 Nov 2025to 31 Mar 2026
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who underwent pancreatic surgery, including pancreaticoduodenectomy (PD), pancreatic-preserving pancreaticoduodenectomy (PPPD), and laparoscopic pancreaticoduodenectomy (LPD)
- Age ≥ 18 years old and < 80 years old
- ASA Ⅰ-Ⅲ
- Be able to clearly understand and voluntarily participate in the research
Who cannot join
- Merging severe primary diseases involving the heart, brain, liver, kidneys and hematopoietic system
- History of long-term use of psychotropic drugs and cognitive dysfunction
- Having a history of acute poisoning from alcohol, sleeping pills, painkillers or other drugs that affect the central nervous system
- Pregnancy or lactation period
- History of allergy to NSAIDs, opioids, or to the test medication
- Drug users, alcoholics, and opiate abusers
- Those who had a history of chronic pain before the operation and a history of long-term use of analgesics and/or sedatives
- Those who had thyroid dysfunction before the operation
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
NanJing drum tower hospital
Nanjing
yudong QIU, 0086+13809021967, yudongqiu510@163.com
1808456151@qq.com
About this study
Official title: The Safety and Efficacy of Aniracetamfen for Postoperative Analgesia and Rehabilitation After Pancreaticoduodenectomy: A Single-center, Single-arm Clinical Study
Exploring the effectiveness and safety of early use of Ariceptinfen after pancreaticoduodenectomy in alleviating postoperative pain and promoting recovery of patients.
Main objective: To explore the analgesic effect of Anricfen after pancreaticoduodenectomy.
Secondary objective: To explore the impact of Anricfen on the accelerated recovery after pancreaticoduodenectomy.
Exploratory objective: To investigate the biomarkers of Anricfen's analgesic effect after pancreaticoduodenectomy, as well as its correlation factors with tumor pathology.
- Being tested
- Experimental Group, Anrikefon
- Keywords
- pancreaticoduodenectomy, Peripheral κ receptor agonist, analgesia, Promote recovery
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperatively, administer Anrikefon injection intravenously at a dose of 1 μg/kg every 8 hours for three consecutive days.
AnrikefonDrug
Postoperatively, intravenous injection of Anrikefon injection was administered at a dose of 1 μg/kg, every 8 hours, for three consecutive days as an intervention
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Other | Postoperatively, administer Anrikefon injection intravenously at a dose of 1 μg/kg every 8 hours for three consecutive days. Receives: Drug: Experimental Group; Drug: Anrikefon |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative complications
Measured: After undergoing treatment for 2 months
Incidence rate of adverse events
Measured: Two month after the treatment
The VAS score within 0-72 hours after the operation
Measured: Within 3 days after receiving treatment
Secondary outcomes (8)
Changes in biochemical indicators and inflammatory indicators
The unit of C-reactive protein is mg/L;The unit of WBC is ×109/L
Measured: One week after the treatment
The time of first flatus and defecation after surgery, and the time to get out of bed for activities
The time of the first postoperative standing up for activities, passing gas, and having a bowel movement is calculated in days. The postoperative hospital stay is also calculated.
Measured: One week after the treatment
Postoperative hospital stay and hospitalization costs
The postoperative hospital stay is calculated in days, and the hospitalization expenses are settled in RMB.
Measured: After undergoing treatment for 2 months
Postoperative analgesia satisfaction scores of the subjects and the satisfaction scores of the study doctors after the administration of the medication were obtained.
The postoperative pain relief satisfaction score and the doctor satisfaction score are calculated on a scale of 0 to 10, with 10 being the highest score.
Measured: Within 3 days after receiving treatment
The initial pressing time of the postoperative analgesic pump, the total number of presses, and the number of effective presses
The number of presses of the postoperative analgesic pump should be recorded based on the actual situation. Each press is counted as 1.
Measured: One day after the treatment
The time for discontinuing postoperative analgesics
Measured: After undergoing treatment for 2 months
The proportion and duration of VAS scores ≤ 3 points within 0-12 hours and 0-24 hours after the first postoperative administration
Measured: Within one day after receiving treatment
The timing and dosage of remedial analgesia
Measured: After undergoing treatment for 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start25 Nov 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Who Undergo PancreaticoduodenectomyStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514637
- Sponsor's protocol ID
- 2025-0770-01
- Status last verified
- Nov 2025
- First submitted
- 4 Feb 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Aniracetamfen for Postoperative Analgesia and Rehabilitation After Pancreaticoduodenectomy: A Single-center, Single-arm Clinical Study
- ClinicalTrials.gov ID
- NCT07514637
- Acronym / sponsor ID
- 2025-0770-01
- Keywords
- pancreaticoduodenectomy, Peripheral κ receptor agonist, analgesia, Promote recovery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 7 Apr 2026 (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.
Exploring the effectiveness and safety of early use of Ariceptinfen after pancreaticoduodenectomy in alleviating postoperative pain and promoting recovery of patients.
Main objective: To explore the analgesic effect of Anricfen after pancreaticoduodenectomy.
Secondary objective: To explore the impact of Anricfen on the accelerated recovery after pancreaticoduodenectomy.
Exploratory objective: To investigate the biomarkers of Anricfen's analgesic effect after pancreaticoduodenectomy, as well as its correlation factors with tumor pathology.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Other | Drug: Experimental Group, Drug: AnrikefonPostoperatively, administer Anrikefon injection intravenously at a dose of 1 μg/kg every 8 hours for three consecutive days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who underwent pancreatic surgery, including pancreaticoduodenectomy (PD), pancreatic-preserving pancreaticoduodenectomy (PPPD), and laparoscopic pancreaticoduodenectomy (LPD)
- Age ≥ 18 years old and < 80 years old
- ASA Ⅰ-Ⅲ
- Be able to clearly understand and voluntarily participate in the research
Key exclusion criteria (8 listed)
- Merging severe primary diseases involving the heart, brain, liver, kidneys and hematopoietic system
- History of long-term use of psychotropic drugs and cognitive dysfunction
- Having a history of acute poisoning from alcohol, sleeping pills, painkillers or other drugs that affect the central nervous system
- Pregnancy or lactation period
- History of allergy to NSAIDs, opioids, or to the test medication
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 |
|---|---|---|
| Experimental GroupPostoperatively, administer Anrikefon injection intravenously at a dose of 1 μg/kg every 8 hours for three consecutive days. | Drug | experimental group |
| AnrikefonPostoperatively, intravenous injection of Anrikefon injection was administered at a dose of 1 μg/kg, every 8 hours, for three consecutive days as an intervention | Drug | experimental group |
Primary outcome
The incidence of postoperative complications
Time frame: After undergoing treatment for 2 months
Incidence rate of adverse events
Time frame: Two month after the treatment
The VAS score within 0-72 hours after the operation
Time frame: Within 3 days after receiving treatment
8 secondary outcomes
Changes in biochemical indicators and inflammatory indicators
Time frame: One week after the treatment
The time of first flatus and defecation after surgery, and the time to get out of bed for activities
Time frame: One week after the treatment
Postoperative hospital stay and hospitalization costs
Time frame: After undergoing treatment for 2 months
Postoperative analgesia satisfaction scores of the subjects and the satisfaction scores of the study doctors after the administration of the medication were obtained.
Time frame: Within 3 days after receiving treatment
The initial pressing time of the postoperative analgesic pump, the total number of presses, and the number of effective presses
Time frame: One day after the treatment
The time for discontinuing postoperative analgesics
Time frame: After undergoing treatment for 2 months
The proportion and duration of VAS scores ≤ 3 points within 0-12 hours and 0-24 hours after the first postoperative administration
Time frame: Within one day after receiving treatment
The timing and dosage of remedial analgesia
Time frame: After undergoing treatment for 2 months
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 Apr 2026.
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 Phase 2 study testing Experimental Group and Anrikefon in people with Patients Who Undergo Pancreaticoduodenectomy, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 4 inclusion and 8 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 Apr 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 yudong QIU (0086+13809021967, yudongqiu510@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative complications (time frame: After undergoing treatment for 2 months). The study lists 3 primary outcomes in all. 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 Apr 2026.