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AzTrials

Pancreatitis, ChronicTESTNCT05270434

Optimal Timing of Endoscopic Intervention in the Treatment of Chronic Pancreatitis.

A study testing time interval between ESWL and ERCP is 12h, time interval between ESWL and ERCP is greater than 12h and morphine, buprenorphine, pethidine, tramaldol, metamizole and acetylsalicylacid (Analgesics) in people with Pancreatitis, Chronic, run by Changhai Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to determine the optimal timing of endoscopic intervention after extracorporeal shock wave lithotripsy(ESWL) of chronic pancreatitis with pancreatic stones. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pancreatitis, Chronic
What is being tested?
time interval between ESWL and ERCP is 12h, time interval between ESWL and ERCP is greater than 12h and morphine, buprenorphine, pethidine, tramaldol, metamizole and acetylsalicylacid (Analgesics)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
1 siteChina
Study dates
12 Mar 2025to 20 Oct 2025
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • symptomatic adult patients diagnosed with chronic pancreatitis and main pancreatic duct positive stones（>5mm in diameter）
  • no ERCP and ESWL history before the admission
  • provides informed consent

Who cannot join

  • suspected to have malignant tumors;
  • history of pancreatic surgery or gastrojejunostomy (Billroth II);
  • with end-stage disease;
  • with contraindications to ESWL or ERCP, such as pregnancy, abdominal aortic aneurysm, etc.
  • acute pancreatitis within 3 days
  • pancreatic ascites

Trial locations and contacts

1 site in 1 country.

China1 site

  • Changhai Hospital

    Shanghai, 200433

Other trials in China

About this study

Official title: Optimal Timing of Endoscopic Intervention After Extracorporeal Shock-Wave Lithotripsy in the Treatment of Chronic Pancreatitis With Pancreatic Stones.

This study aims to determine the optimal timing of endoscopic intervention after extracorporeal shock wave lithotripsy(ESWL) of chronic pancreatitis with pancreatic stones.

Read the detailed description

Chronic pancreatitis（CP）is a chronic progressive fibro-inflammatory disease of the pancreas induced by a wide range of factors including genetic and environmental elements, with recurrent abdominal pain and pancreatic secretion insufficiency as its major clinical signs. Chronic pancreatitis is not only a tough disease of the gastrointestinal system but also a worldwide medical problem. At present, the MESS (medicine-extracorporeal shock wave lithotripsy-endoscopic retrograde cholangiopancreatography-surgery）formed by changhai hospital in CP diagnosis and treatment is gradually becoming mature, and the clinical effect of this system is obvious. However, there are still some difficulties and knowledge gaps in the clinical treatment of CP. Currently, it is recommended by both domestic and foreign guidelines that ERCP combined with ESWL as the first-line treatment pattern for patients with chronic pancreatitis associate pain. It has previously been observed that ERCP performed less than 2 days after ESWL may be more likely to fail, possibly owing to ESWL-induced edema. However, there is no high-quality research to demonstrate how to choose the most optimal timing of ERCP after ESWL for patients with indications for endoscopic treatment. This prospective, randomized controlled research has therefore aimed to determine the most optimal timing of ERCP after ESWL. Patients with painful chronic pancreatitis and pancreatic stones larger than 5 mm in diameter will be randomly and equally assigned to two groups, which are divided according to the time interval between ESWL and ERCP, including the same day (< 12 hours) subgroup and the next day ( ≥12 hours) subgroup. The cannulation success rate and stone clearance rate of the pancreatic duct will be assessed in each group to explore the most appropriate timing of ERCP, and then provide an important reference basis for the clinical treatment of chronic pancreatitis.

Being tested
time interval between ESWL and ERCP is 12h, time interval between ESWL and ERCP is greater than 12h, morphine, buprenorphine, pethidine, tramaldol, metamizole and acetylsalicylacid (Analgesics)
Keywords
Extracorporeal Shock Wave Lithotripsy(ESWL), Chronic pancreatitis, Endoscopic Retrograde Cholangiopancreatography(ERCP), Pancreatic stones
Medical subject headings
Pancreatitis, Chronic

What participants receive

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

  • time interval between ESWL and ERCP is 12hProcedure or surgery

    Also called ESWL, ERCP

    The patients received intravenous analgesia before the ESWL. After the last ESWL session, the patients are treated with following ERCP within 12h.

  • time interval between ESWL and ERCP is greater than 12hProcedure or surgery

    Also called ESWL, ERCP

    The patients received intravenous analgesia before the ESWL. After the last ESWL session, the patients are treated with following ERCP ≥12 h.

  • morphine, buprenorphine, pethidine, tramaldol, metamizole and acetylsalicylacid (Analgesics)Drug

    Analgesics administrated include morphine, buprenorphine, pethidine, tramaldol, metamizole and acetylsalicylacid. They will only be administrated as needed.

Study groups in NCT05270434
Study groupRoleWhat they receive
Endoscopic group <12hExperimentalThe patients received intravenous analgesia (flurbiprofen and remifentanil) before the ESWL (Compact Delta II; Dornier Med Tech, Wessling, Germany). After the last ESWL session, the patients are treated with following ERCP within 12h. ERCP was performed under conscious sedation with intramuscular administration of diazepam 2.5-5.0 mg and pethidine 25-50 mg. If necessary, endoscopic sphincterotomy was performed. A dilating bougie or balloon will be used to dilate the stenosis after sphincterotomy. Standard techniques (i.e., extraction basket, extraction balloon, or both) will be used for stone removal. A pancreatic duct stent for drainage and nasopancreatic catheters will be inserted for temporary drainage if necessary.
Receives: Procedure: time interval between ESWL and ERCP is 12h; Drug: morphine, buprenorphine, pethidine, tramaldol, metamizole and acetylsalicylacid (Analgesics)
Endoscopic group ≥12 hActive comparatorThe patients received intravenous analgesia (flurbiprofen and remifentanil) before the ESWL (Compact Delta II; Dornier Med Tech, Wessling, Germany). The time scale between the last ESWL session and following ERCP is greater than 12h. ERCP was performed under conscious sedation with intramuscular administration of diazepam 2.5-5.0 mg and pethidine 25-50 mg. If necessary, endoscopic sphincterotomy was performed. A dilating bougie or balloon will be used to dilate the stenosis after sphincterotomy. Standard techniques (i.e., extraction basket, extraction balloon, or both) will be used for stone removal. A pancreatic duct stent for drainage and nasopancreatic catheters will be inserted for temporary drainage if necessary.
Receives: Procedure: time interval between ESWL and ERCP is greater than 12h; Drug: morphine, buprenorphine, pethidine, tramaldol, metamizole and acetylsalicylacid (Analgesics)

What is being measured

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

  1. Successful MPD Cannulation Rates

    technical success rate of pancreatic cannulation

    Measured: during ERCP procedure

Secondary outcomes (3)

  1. Successful clearance of MPD stones

    Ductal clearance has been defined as complete, partial, or unsuccessful if the proportion of stones cleared was > 90 %, 50 %-90 %, or < 50 %, respectively.

    Measured: during ERCP procedure

  2. post-ERCP complications

    Major post-ERCP complications includes post-ERCP pancreatitis, bleeding, infection, and perforation, which are classified as mild, moderate, or severe, depending mainly on the length of hospitalization and the need for invasive treatment.

    Measured: 30 days

  3. severity of post-ERCP complications

    severity are classified as mild, moderate, or severe, depending mainly on the length of hospitalization and the need for invasive treatment.

    Measured: 30 days

Timeline

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

  1. First posted8 Mar 2022
  2. Study start12 Mar 2025
  3. Primary completion18 Oct 2025
  4. Study completion20 Oct 2025

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
Single blind
Who is masked
Outcomes assessor
Enrolment
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05270434
Sponsor's protocol ID
Optimal Timing of Endoscopic
Acronym
TEST
Status last verified
Nov 2025
First submitted
10 Jan 2022
Last updated
19 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Guo JY, Qian YY, Sun H, Chen H, Zou WB, Hu LH, Li ZS, Xin L, Liao Z. Optimal Timing of Endoscopic Intervention After Extracorporeal Shock-Wave Lithotripsy in the Treatment of Chronic Calcified Pancreatitis. Pancreas. 2021 Apr 1;50(4):633-638. doi: 10.1097/MPA.0000000000001810.

    PubMed 33939679

Questions about this trial

What is this clinical trial studying?

A study testing time interval between ESWL and ERCP is 12h, time interval between ESWL and ERCP is greater than 12h and morphine, buprenorphine, pethidine, tramaldol, metamizole and acetylsalicylacid (Analgesics) in people with Pancreatitis, Chronic, run by Changhai 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 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: finished, as of the sponsor's last update on 19 Nov 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Successful MPD Cannulation Rates (time frame: during ERCP procedure). 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 NCT05270434, 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 19 Nov 2025.

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