Acute Necrotizing PancreatitisNCT07080697
A Study to Evaluate Splenectomy on Debridement for Acute Necrotizing Pancreatitis With Pancreatic Sinistral Portal Hypertension
A study testing Splenectomy in people with Acute Necrotizing Pancreatitis and Portal Hypertension, run by Zhejiang University at 1 site in China.
Trial summary
This study is a prospective, single-center, randomized controlled trial focusing on patients with acute necrotizing pancreatitis (ANP) complicated by pancreatic sinistral portal hypertension (PSPH). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Necrotizing Pancreatitis, Portal Hypertension
- What is being tested?
- Splenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2025to 29 Feb 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years.
- Acute necrotic pancreatitis complicated by pancreatic sinistral portal hypertension.
- Patients undergoing open debridement for infected pancreatic necrosis
Who cannot join
- Patients with pre-existing heart, lung, liver, kidney, or other organ failure prior to acute pancreatitis (AP).
- Patients with pre-existing conditions such as cirrhosis that may lead to portal hypertension prior to AP.
- Patients with pre-existing hematological diseases prior to AP.
- Patients undergoing laparoscopic or nephroscopic debridement.
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
First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Ting-Bo Liang, 086-571-87236688, liangtingbo@zju.edu.cn
About this study
Official title: The Impact of Splenectomy on Debridement Efficacy, Perioperative Recovery, and Prognosis in Patients With Acute Necrotizing Pancreatitis Complicated by Pancreatic Sinistral Portal Hypertension
This study is a prospective, single-center, randomized controlled trial focusing on patients with acute necrotizing pancreatitis (ANP) complicated by pancreatic sinistral portal hypertension (PSPH). The study aims to study the impact of total splenectomy on the debridement efficacy, perioperative recovery, and prognosis of patients with ANP complicated by PSPH.
Read the detailed description
This study is a prospective, single-center, randomized controlled trial focusing on patients with acute necrotizing pancreatitis (ANP) complicated by pancreatic sinistral portal hypertension (PSPH). A total of 66 participants are planned to be enrolled. The study aims to compare the outcomes of two surgical approaches: open debridement combined with distal pancreatectomy and total splenectomy versus open debridementalone. The objective is to observe the impact of total splenectomy on the debridement efficacy, perioperative recovery, and prognosis of patients with ANP complicated by PSPH. The primary observational indicators include postoperative length of hospital stay, postoperative cost, postoperative life quality, and the alleviation of PSPH. Secondary observational indicators encompass the number of unplanned reoperations, postoperative infection control, postoperative irrigation volume, postoperative antibiotic consumption, and postoperative platelet count change. The study will be carried out in accordance with the protocol.
- Being tested
- Splenectomy, Control
- Keywords
- Acute Necrotizing Pancreatitis, Pancreatic Sinistral Portal Hypertension, Debridement, Splenectomy
- Medical subject headings
- Pancreatitis, Acute Necrotizing, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SplenectomyProcedure or surgery
Open Debridement combined with distal pancreatectomy and total splenectomy
ControlProcedure or surgery
Open Debridement alone
| Study group | Role | What they receive |
|---|---|---|
| Splenectomy group | Experimental | Open Debridement combined with Distal Pancreatectomy and Total Splenectomy Receives: Procedure: Splenectomy |
| Control group | Experimental | Open Debridement alone Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay after debridement
The total length of hospital stay after debridement, including readmissions.
Measured: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)
Degree of pancreatic sinistral portal hypertension
The degree of pancreatic sinistral portal hypertension after intervention
Measured: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)
Secondary outcomes (11)
Intensive Care Unit stay post Operation
Measured: Perioperative
Pancreatic Fistula
The rate of pancreatic fistula
Measured: Perioperative
Number of Draining Tube when Discharged
Measured: Perioperative
Time of all draining tubes removal
Measured: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)
Cost post debridement in the first hospitalization
Measured: Perioperative
Number of unplanned re-admissions
Measured: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)
Number of unplanned operations
Measured: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)
Number of percutaneous drainage after debridement
Measured: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)
Antibiotic use after treatment
Measured: Perioperative
Abdominal lavage
Abdominal lavage volume after treatment
Measured: Perioperative
Life quality one year after treatment
Life quality one year after treatment was judged by the Short-Form 36 Health Survey (SF-36), encompassing both physical and mental health across eight dimensions: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The minimum value is 0%, the maximum value is 100%, and a higher score means a better life quality.
Measured: Within one year after the last subject was treated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start30 Jul 2025 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Necrotizing PancreatitisStudies of the same condition, open and under way.
- 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
- Model description
- One group will receive open debridement combined with distal pancreatectomy and total splenectomy, the other group will receive open debridement alone.
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TingBo Liang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080697
- Sponsor's protocol ID
- IIT20250028C
- Status last verified
- Jul 2025
- First submitted
- 4 Jul 2025
- Last updated
- 23 Jul 2025
- 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 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Splenectomy on Debridement Efficacy, Perioperative Recovery, and Prognosis in Patients With Acute Necrotizing Pancreatitis Complicated by Pancreatic Sinistral Portal Hypertension
- ClinicalTrials.gov ID
- NCT07080697
- Acronym / sponsor ID
- IIT20250028C
- Keywords
- Acute Necrotizing Pancreatitis, Pancreatic Sinistral Portal Hypertension, Debridement, Splenectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 30 Jul 2025 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 23 Jul 2025 (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.
This study is a prospective, single-center, randomized controlled trial focusing on patients with acute necrotizing pancreatitis (ANP) complicated by pancreatic sinistral portal hypertension (PSPH). The study aims to study the impact of total splenectomy on the debridement efficacy, perioperative recovery, and prognosis of patients with ANP complicated by PSPH.
Detailed description
This study is a prospective, single-center, randomized controlled trial focusing on patients with acute necrotizing pancreatitis (ANP) complicated by pancreatic sinistral portal hypertension (PSPH). A total of 66 participants are planned to be enrolled. The study aims to compare the outcomes of two surgical approaches: open debridement combined with distal pancreatectomy and total splenectomy versus open debridementalone. The objective is to observe the impact of total splenectomy on the debridement efficacy, perioperative recovery, and prognosis of patients with ANP complicated by PSPH. The primary observational indicators include postoperative length of hospital stay, postoperative cost, postoperative life quality, and the alleviation of PSPH. Secondary observational indicators encompass the number of unplanned reoperations, postoperative infection control, postoperative irrigation volume, postoperative antibiotic consumption, and postoperative platelet count change. The study will be carried out in accordance with the protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One group will receive open debridement combined with distal pancreatectomy and total splenectomy, the other group will receive open debridement alone.
| Arm | Type | Receives |
|---|---|---|
| Splenectomy group | Experimental | Procedure: SplenectomyOpen Debridement combined with Distal Pancreatectomy and Total Splenectomy |
| Control group | Experimental | Procedure: ControlOpen Debridement alone |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 75 years.
- Acute necrotic pancreatitis complicated by pancreatic sinistral portal hypertension.
- Patients undergoing open debridement for infected pancreatic necrosis
Key exclusion criteria (4 listed)
- Patients with pre-existing heart, lung, liver, kidney, or other organ failure prior to acute pancreatitis (AP).
- Patients with pre-existing conditions such as cirrhosis that may lead to portal hypertension prior to AP.
- Patients with pre-existing hematological diseases prior to AP.
- Patients undergoing laparoscopic or nephroscopic debridement.
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 |
|---|---|---|
| SplenectomyOpen Debridement combined with distal pancreatectomy and total splenectomy | Procedure or surgery | Splenectomy group |
| ControlOpen Debridement alone | Procedure or surgery | Control group |
Primary outcome
Length of hospital stay after debridement
Time frame: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)
The total length of hospital stay after debridement, including readmissions.
Degree of pancreatic sinistral portal hypertension
Time frame: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)
The degree of pancreatic sinistral portal hypertension after intervention
11 secondary outcomes
Intensive Care Unit stay post Operation
Time frame: Perioperative
Pancreatic Fistula
Time frame: Perioperative
Number of Draining Tube when Discharged
Time frame: Perioperative
Time of all draining tubes removal
Time frame: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)
Cost post debridement in the first hospitalization
Time frame: Perioperative
Number of unplanned re-admissions
Time frame: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)
Number of unplanned operations
Time frame: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)
Number of percutaneous drainage after debridement
Time frame: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)
Antibiotic use after treatment
Time frame: Perioperative
Abdominal lavage
Time frame: Perioperative
Life quality one year after treatment
Time frame: Within one year after the last subject was treated
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 23 Jul 2025.
- 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 Splenectomy in people with Acute Necrotizing Pancreatitis and Portal Hypertension, run by Zhejiang University 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: looking for participants now, as of the sponsor's last update on 23 Jul 2025. 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 Yun Zhang (086-18058715288, bigzyun1977@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay after debridement (time frame: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)). The study lists 2 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 23 Jul 2025.