AzTrials
AzTrials

Severe Acute PancreatitisNCT04813510

Effect of Electroacupuncture on SAP With MODS

A study testing electroacupuncture treatment in people with Severe Acute Pancreatitis, run by Jianbo Yu.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

1. Title: Effect of Electroacupuncture on Severe Acute Pancreatitis with Multiple Organ Disfunction Syndrome patients: A Randomized Clinical Trial 2. Research center: single center 3. Design of the research: A randomized, double-blind and parallel controlled study 4. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Severe Acute Pancreatitis
What is being tested?
electroacupuncture treatment
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
110 participants
Where
No sites listed yet
Study dates
22 Dec 2021to 30 Jun 2023
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 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Meet the diagnosis of severe acute pancreatitis (Atlanta diagnostic criteria), within 1 week of onset
  • Combine 2 or more organ failures at the same time, and the duration is greater than 48h
  • Age ≥18 years old;
  • Obtain informed consent.

Who cannot join

  • Pregnancy pancreatitis;
  • Patients who have undergone percutaneous puncture or surgical drainage before admission, and have undergone surgical decompression due to early abdominal hypertension;
  • Patients with a history of chronic organ dysfunction (such as uremia, COPD, liver cirrhosis, heart failure, etc.).
  • Those who have a medical history of acupuncture and moxibustion or are not sensitive to acupuncture and moxibustion.
  • Those who refuse to participate in the research

Trial locations and contacts

No sites are listed yet.

Yingya Cao, MD contact

15055324662

caoyingya1990@126.com

About this study

Official title: Effect of Electroacupuncture on SAP With MODS: a Prospective, Double-blind, Randomized Controlled Trial

  1. Title: Effect of Electroacupuncture on Severe Acute Pancreatitis with Multiple Organ Disfunction Syndrome patients: A Randomized Clinical Trial
  2. Research center: single center
  3. Design of the research: A randomized, double-blind and parallel controlled study
  4. Object of the research: The patients over 18 years that met the criteria of SAP and with more than 2 organs failure.
  5. Sample size of the research: A total of 220patients,110 cases in each group
  6. Interventions: The acupuncture points for electroacupuncture are Zusanli(ST36), Xiajuxu(ST39), Hegu(LI4), Neiguan(PC6) points . Participants in the treatment group underwent 30 minutes acupuncture (0.30mm×70mm) at above points once a day for seven days. After"Deqi",electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China) is connected and maintained the end of treatment. Participants in the control group received shallow needling (0.30mm×25mm) at nonacupoints (located 1 inch beside acupoints). Specifically, the depth of needle insertion into nonacupoints is 3-5mm and avoided manual stimulation and no "Deqi" without actual current output.
  7. Aim of the research: To investigate the effect of electroacupuncture on Severe Acute Pancreatitis with Multiple Organ Disfunction Syndrome.
  8. Outcome #Primary outcomes: All-cause 28-day mortality. Secondary outcomes: Duration of organ failure; The incidence of pancreatic necrotic tissue infection; Time for enteral nutrition to reach the standard (30kcal/kg); Mechanical ventilation time; Length of hospital stay
  9. The estimated duration of the study#2 years.
Read the detailed description

This study is a randomized, double-blinded, placebo controlled and long-term follow-up design. In this study, Zusanli(ST36), Xiajuxu(ST39), Hegu(LI4), Neiguan(PC6) were selected for electroacupuncture treatment, accompanied with evaluating the effects on 28-day mortality in SAP patients with MODS, as well as the duration of organ failure, the incidence of pancreatic necrotic tissue infection and length of hospital stay . To clarify the effect of electroacupuncture on SAP patients with MODS is of great significance to the clinical applications and popularization of traditional acupuncture treatment across the world.

Being tested
electroacupuncture treatment, sham electroacupuncture treatment
Keywords
Severe Acute Pancreatitis, Multiple Organ Disfunction Syndrome
Medical subject headings
Pancreatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • electroacupuncture treatmentDevice

    Participants in the treatment group underwent 60 minutes acupuncture (0.30mm×70mm) at Zusanli(ST36), Xiajuxu(ST39), Hegu(LI4), Neiguan(PC6) once a day for seven days. After"Deqi", electroacupuncture stimulation apparatus(HANS G6805-2, Huayi Co, Shanghai, China) is connected with the density wave (2/100 Hz), width 0.25 ms, intensity of 1 ~ 30 mA (gradually increase to the patient's maximum tolerance) and maintained the end of treatment.

  • sham electroacupuncture treatmentDevice

    Participants in the sham electroacupuncture group received shallow needling (0.30mm×25mm) at nonacupoints (located 1 inch beside acupoints).. Specifically, the depth of needle insertion into nonacupoints is 3-5mm and avoided manual stimulation and no "Deqi" without actual current output, and retained the needle for the same time as treatment group

Study groups in NCT04813510
Study groupRoleWhat they receive
electroacupuncture treatmentExperimentalParticipants in the treatment group underwent 30 minutes acupuncture (0.30mm×70mm) at Zusanli(ST36), Xiajuxu(ST39), Hegu(LI4), Neiguan(PC6) once a day for seven days. After"Deqi",electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China) isconnected and maintained the end of treatment.
Receives: Device: electroacupuncture treatment
sham electroacupuncture treatmentSham comparatorParticipants in the control group received shallow needling (0.30mm×25mm) at nonacupoints (located 1 inch beside acupoints). Specifically, the depth of needle insertion into nonacupoints is 3-5mm and avoided manual stimulation and no "Deqi" without actual current output.
Receives: Device: sham electroacupuncture treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause 28-day mortality

    All reasons (such as infection, hemorrhage) caused the mortality during the first 28 days after treatments

    Measured: 1-2year

Secondary outcomes (4)

  1. Duration of organ failure

    The time of organ failure recovered

    Measured: an average of 1-2 year

  2. The incidence of pancreatic necrotic tissue infection

    The incidence of pancreatic necrotic tissue infection

    Measured: up to one year

  3. Duration of mechanical ventilation in patients with endotracheal intubation in ICU

    Duration of mechanical ventilation in patients with endotracheal intubation in ICU

    Measured: an average of 1 year

  4. Length of stay in hospital

    ICU stay time and hospitalization time

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2021
  2. Study start22 Dec 2021 (estimated)
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion30 Jun 2023 (estimated)

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04813510
Sponsor's protocol ID
EA-SAP-202103
Status last verified
Dec 2021
First submitted
22 Mar 2021
Last updated
22 Dec 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Bakker OJ, van Brunschot S, van Santvoort HC, Besselink MG, Bollen TL, Boermeester MA, Dejong CH, van Goor H, Bosscha K, Ahmed Ali U, Bouwense S, van Grevenstein WM, Heisterkamp J, Houdijk AP, Jansen JM, Karsten TM, Manusama ER, Nieuwenhuijs VB, Schaapherder AF, van der Schelling GP, Schwartz MP, Spanier BW, Tan A, Vecht J, Weusten BL, Witteman BJ, Akkermans LM, Bruno MJ, Dijkgraaf MG, van Ramshorst B, Gooszen HG; Dutch Pancreatitis Study Group. Early versus on-demand nasoenteric tube feeding in acute pancreatitis. N Engl J Med. 2014 Nov 20;371(21):1983-93. doi: 10.1056/NEJMoa1404393.

    PubMed 25409371

  • Kohli P, Gupta V, Kochhar R, Yadav TD, Sinha SK, Lal A. Lavage through percutaneous catheter drains in severe acute pancreatitis: Does it help?A randomized control trial. Pancreatology. 2019 Oct;19(7):929-934. doi: 10.1016/j.pan.2019.09.003. Epub 2019 Sep 9.

    PubMed 31521496

  • Karjula H, Nordblad Schmidt P, Makela J, Liisanantti JH, Ohtonen P, Saarela A. Prophylactic pancreatic duct stenting in severe acute necrotizing pancreatitis: a prospective randomized study. Endoscopy. 2019 Nov;51(11):1027-1034. doi: 10.1055/a-0865-1960. Epub 2019 Mar 20.

    PubMed 30895583

  • Liu Z, Yan S, Wu J, He L, Li N, Dong G, Fang J, Fu W, Fu L, Sun J, Wang L, Wang S, Yang J, Zhang H, Zhang J, Zhao J, Zhou W, Zhou Z, Ai Y, Zhou K, Liu J, Xu H, Cai Y, Liu B. Acupuncture for Chronic Severe Functional Constipation: A Randomized Trial. Ann Intern Med. 2016 Dec 6;165(11):761-769. doi: 10.7326/M15-3118. Epub 2016 Sep 13.

    PubMed 27618593

  • Liu Z, Liu Y, Xu H, He L, Chen Y, Fu L, Li N, Lu Y, Su T, Sun J, Wang J, Yue Z, Zhang W, Zhao J, Zhou Z, Wu J, Zhou K, Ai Y, Zhou J, Pang R, Wang Y, Qin Z, Yan S, Li H, Luo L, Liu B. Effect of Electroacupuncture on Urinary Leakage Among Women With Stress Urinary Incontinence: A Randomized Clinical Trial. JAMA. 2017 Jun 27;317(24):2493-2501. doi: 10.1001/jama.2017.7220.

    PubMed 28655016

Questions about this trial

What is this clinical trial studying?

A study testing electroacupuncture treatment in people with Severe Acute Pancreatitis, run by Jianbo Yu.

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 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: status not confirmed, as of the sponsor's last update on 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

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.

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 Yingya Cao, MD (15055324662, caoyingya1990@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause 28-day mortality (time frame: 1-2year). 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 NCT04813510, which also lists 5 linked publications.

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 22 Dec 2021.

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