Pancreatitis, Acute NecrotizingNCT02133014
The Study of Laparoscopic-assisted Percutaneous Catheter-directed Drainage to Treat Early Severe Acute Pancreatitis
A study testing laparoscopic-assisted percutaneous catheter drainage and 0.5% 5-fluorouracil normal saline in people with Pancreatitis, Acute Necrotizing, run by Zhujiang Hospital at 1 site in China.
Trial summary
The purpose of this study is to analyze the effect of laparoscopic-assisted percutaneous catheter drainage of early SAP(severe acute pancreatitis).We are going to select 60 cases SAP patients from April 2014 to April 2015 who carry on the treatment in our hospital,and divide into the experimental group and control… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Pancreatitis, Acute Necrotizing
- What is being tested?
- laparoscopic-assisted percutaneous catheter drainage and 0.5% 5-fluorouracil normal saline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Apr 2014to Apr 2015
- Phase
- Interventional
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- mild acute pancreatitis;
- chronic acute pancreatitis;
- on admission has received surgical treatment;
- pregnant and lactating women ;combined with heart,lung,liver,kidney severe primary disease;psychopath;
- malignant tumor
- immunocompromised state.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Hepatobiliary Surgery(I),Zhujiang Hospital
Guangzhou, Guangdong, 510280
Fan y fang, Prof.
About this study
Official title: The Study of Laparoscopic-assisted Percutaneous Catheter-directed Drainage to Treat Early Severe Acute Pancreatitis in Chinese Population.
The purpose of this study is to analyze the effect of laparoscopic-assisted percutaneous catheter drainage of early SAP(severe acute pancreatitis).We are going to select 60 cases SAP patients from April 2014 to April 2015 who carry on the treatment in our hospital,and divide into the experimental group and control group under respect the wishes of patient in the case.The experimental group use the method of laparoscopic-assisted percutaneous drainage to carry on the treatment,the control group patients use conventional conservative therapy to carry on the treatment.Contrastive analyze two groups of patients clinical care effects.
Research hypothesis:according to compare the mortality,the incidence of complications ,hospital stay and other research indicators of two groups .It is supposed that the research indicators of experimental group are lower than the control group ,difference was statistically significant(P<0.05).We can draw the conclusion that the method of laparoscopic-assisted percutaneous catheter drainage of early SAP is useful and deserve to be promoted on clinical.
Read the detailed description
According to the unified inclusion and exclusion criteria,We are going to select 60 cases SAP patients who carry on the treatment in our hospital from April 2014 to April 2015,and divide into the experimental group and control group under respect the wishes of patients.
The experimental group use the method of laparoscopic-assisted percutaneous catheter-directed drainage of SAP.According to different causes,.For patients with simple gallbladder stones,it is going to carry out by laparoscopic cholecystectomy or cholecystotomy.For patients with both gallbladder and common bile duct stones,common bile duct exploration is performed.Removing necrotic pancreatic organizations and putting the catheter around the region of pancreas.After the surgery,patient's cavity are continuously douched by catheter using 0.5% 5-fluorouracil normal saline.The postoperation therapeutic program is same as the control group.
The control group use the method of conventional conservative therapy without surgical management,the principles of treatment include:(1)fasting,insert gastric tube,gastrointestinal decompression;(2)complement of blood volume,keeping water ,electrolyte and acid base balance;(3)inhibiting pancreatic enzyme and acid secretion;(4)using broad-spectrum antibiotic at the early phase;(5)improving microcirculation,dextrans and FuFangdanshen by IV;(6)early parenteral nutrition;(7)treatment by chinese herbs;(8)strengthen the function of important organs.
Contrastive analyse two groups of patient's mortality,the incidence of complications,hospital stay,laboratory tests and other research indicators.
- Conditions
- Pancreatitis, Acute Necrotizing
- Being tested
- laparoscopic-assisted percutaneous catheter drainage, 0.5% 5-fluorouracil normal saline
- Keywords
- pancreatitis, laparoscopic, drainage, surgery
- Medical subject headings
- Pancreatitis, Acute Necrotizing, Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic-assisted percutaneous catheter drainageProcedure or surgery
Also called surgical therapy
Removing necrotic pancreatic organizations and putting the catheter around the region of pancreas.After the surgery,patient's cavity are continuously douched by catheter using 0.5% 5-fluorouracil normal saline
0.5% 5-fluorouracil normal salineDrug
Also called 5-FU, f5U
On the one hand,0.5% 5-fluorouracil normal saline directly inhibit DNA synthesis of pancreatic acinar cells which result in the synthesis of amylopsin of and trypsase is restrained.On the other hand,it can induce pancreatic cells apoptosis and alleviate pancreatic necrosis.
| Study group | Role | What they receive |
|---|---|---|
| surgical operation therapy | Experimental | Using the method of laparoscopic-assisted percutaneous catheter drainage of SAP.After the surgery,patient's cavity are continuously douched by catheter using 0.5% 5-fluorouracil normal saline. Receives: Procedure: laparoscopic-assisted percutaneous catheter drainage; Drug: 0.5% 5-fluorouracil normal saline |
| conventional therapy | No intervention | using the method of conventional conservative therapy without surgical management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
Measured: one year
Secondary outcomes (1)
the incidence of local Complications
the local complications include:pancreatic necrosis,pancreatic abscess,pancreatic pseudocyst etc.
Measured: within the first 30 days (plus or minus 3 days) after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatitis, Acute NecrotizingStudies of the same condition, open and under way.
- More trials run by Zhujiang 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fan y fang, Prof., Principal investigator, Department of Hepatobiliary Surgery(I),Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02133014
- Sponsor's protocol ID
- Fanyingfang1
- Status last verified
- Apr 2014
- First submitted
- 28 Apr 2014
- Last updated
- 7 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Echenique AM, Sleeman D, Yrizarry J, Scagnelli T, Guerra JJ Jr, Casillas VJ, Huson H, Russell E. Percutaneous catheter-directed debridement of infected pancreatic necrosis: results in 20 patients. J Vasc Interv Radiol. 1998 Jul-Aug;9(4):565-71. doi: 10.1016/s1051-0443(98)70323-9.
PubMed 9684824
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Laparoscopic-assisted Percutaneous Catheter-directed Drainage to Treat Early Severe Acute Pancreatitis in Chinese Population.
- ClinicalTrials.gov ID
- NCT02133014
- Acronym / sponsor ID
- Fanyingfang1
- Conditions
- Pancreatitis, Acute Necrotizing
- Keywords
- pancreatitis, laparoscopic, drainage, surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 7 May 2014 (estimated)
- 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 purpose of this study is to analyze the effect of laparoscopic-assisted percutaneous catheter drainage of early SAP(severe acute pancreatitis).We are going to select 60 cases SAP patients from April 2014 to April 2015 who carry on the treatment in our hospital,and divide into the experimental group and control group under respect the wishes of patient in the case.The experimental group use the method of laparoscopic-assisted percutaneous drainage to carry on the treatment,the control group patients use conventional conservative therapy to carry on the treatment.Contrastive analyze two groups of patients clinical care effects.
Research hypothesis:according to compare the mortality,the incidence of complications ,hospital stay and other research indicators of two groups .It is supposed that the research indicators of experimental group are lower than the control group ,difference was statistically significant(P<0.05).We can draw the conclusion that the method of laparoscopic-assisted percutaneous catheter drainage of early SAP is useful and deserve to be promoted on clinical.
Detailed description
According to the unified inclusion and exclusion criteria,We are going to select 60 cases SAP patients who carry on the treatment in our hospital from April 2014 to April 2015,and divide into the experimental group and control group under respect the wishes of patients.
The experimental group use the method of laparoscopic-assisted percutaneous catheter-directed drainage of SAP.According to different causes,.For patients with simple gallbladder stones,it is going to carry out by laparoscopic cholecystectomy or cholecystotomy.For patients with both gallbladder and common bile duct stones,common bile duct exploration is performed.Removing necrotic pancreatic organizations and putting the catheter around the region of pancreas.After the surgery,patient's cavity are continuously douched by catheter using 0.5% 5-fluorouracil normal saline.The postoperation therapeutic program is same as the control group.
The control group use the method of conventional conservative therapy without surgical management,the principles of treatment include:(1)fasting,insert gastric tube,gastrointestinal decompression;(2)complement of blood volume,keeping water ,electrolyte and acid base balance;(3)inhibiting pancreatic enzyme and acid secretion;(4)using broad-spectrum antibiotic at the early phase;(5)improving microcirculation,dextrans and FuFangdanshen by IV;(6)early parenteral nutrition;(7)treatment by chinese herbs;(8)strengthen the function of important organs.
Contrastive analyse two groups of patient's mortality,the incidence of complications,hospital stay,laboratory tests and other research indicators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgical operation therapy | Experimental | Procedure: laparoscopic-assisted percutaneous catheter drainage, Drug: 0.5% 5-fluorouracil normal salineUsing the method of laparoscopic-assisted percutaneous catheter drainage of SAP.After the surgery,patient's cavity are continuously douched by catheter using 0.5% 5-fluorouracil normal saline. |
| conventional therapy | No intervention | –using the method of conventional conservative therapy without surgical management. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- mild acute pancreatitis;
- chronic acute pancreatitis;
- on admission has received surgical treatment;
- pregnant and lactating women ;combined with heart,lung,liver,kidney severe primary disease;psychopath;
- malignant tumor
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 |
|---|---|---|
| laparoscopic-assisted percutaneous catheter drainageAlso: surgical therapyRemoving necrotic pancreatic organizations and putting the catheter around the region of pancreas.After the surgery,patient's cavity are continuously douched by catheter using 0.5% 5-fluorouracil normal saline | Procedure or surgery | surgical operation therapy |
| 0.5% 5-fluorouracil normal salineAlso: 5-FU, f5UOn the one hand,0.5% 5-fluorouracil normal saline directly inhibit DNA synthesis of pancreatic acinar cells which result in the synthesis of amylopsin of and trypsase is restrained.On the other hand,it can induce pancreatic cells apoptosis and alleviate pancreatic necrosis. | Drug | surgical operation therapy |
Primary outcome
mortality
Time frame: one year
1 secondary outcome
the incidence of local Complications
Time frame: within the first 30 days (plus or minus 3 days) after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2014.
- Results publication: PubMed 9684824Echenique AM, Sleeman D, Yrizarry J, Scagnelli T, Guerra JJ Jr, Casillas VJ, Huson H, Russell E. Percutaneous catheter-directed debridement of infected pancreatic necrosis: results in 20 patients. J Vasc Interv Radiol. 1998 Jul-Aug;9(4):565-71. doi: 10.1016/s1051-0443(98)70323-9.
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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.
Fan y fang, Prof. principal investigator
Department of Hepatobiliary Surgery(I),Zhujiang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic-assisted percutaneous catheter drainage and 0.5% 5-fluorouracil normal saline in people with Pancreatitis, Acute Necrotizing, run by Zhujiang 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 0 inclusion and 6 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 May 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wang li qing, doctor (+86-02062783391, wliqing07@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02133014, which also lists 1 linked publication.
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 May 2014.