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Completed

NCT Number: NCT05270434

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

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changhai Hospital

Shanghai, 200433, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

time interval between ESWL and ERCP is 12h

Procedure

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

Other names: ESWL, ERCP

time interval between ESWL and ERCP is greater than 12h

Procedure

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

Other names: ESWL, ERCP

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.

Primary outcomes

  1. Successful MPD Cannulation Rates

    Time frame: during ERCP procedure

    technical success rate of pancreatic cannulation

Secondary outcomes

  1. Successful clearance of MPD stones

    Time frame: during ERCP procedure

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

  2. post-ERCP complications

    Time frame: 30 days

    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.

  3. severity of post-ERCP complications

    Time frame: 30 days

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

Other outcomes

  1. Treatment-related costs in RMB from initial enrollment to the end of the study

    Time frame: through endotherapy completion, an average of 14days

    The total costs in RMB of each hospitalization

  2. The hospitalization time

    Time frame: through endotherapy completion, an average of 14days

    Length of hospitalization due to ESWL /ERCP and complications

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

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

Acronym: TEST

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 8, 2022
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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