Optimal Timing of Endoscopic Intervention in the Treatment of Chronic Pancreatitis. (TEST)

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.

Study Overview

• Status: Completed
• Conditions: Pancreatitis, Chronic
• Intervention / Treatment: Procedure: time interval between ESWL and ERCP is 12h; Drug: morphine, buprenorphine, pethidine, tramaldol, metamizole and acetylsalicylacid (Analgesics); Procedure: time interval between ESWL and ERCP is greater than 12h

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.

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200433
    • Changhai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endoscopic group <12h; The 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.	Procedure: time interval between ESWL and ERCP is 12h; 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; Drug: morphine, buprenorphine, pethidine, tramaldol, metamizole and acetylsalicylacid (Analgesics); Analgesics administrated include morphine, buprenorphine, pethidine, tramaldol, metamizole and acetylsalicylacid. They will only be administrated as needed.
Active Comparator: Endoscopic group ≥12 h; The 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.	Drug: morphine, buprenorphine, pethidine, tramaldol, metamizole and acetylsalicylacid (Analgesics); Analgesics administrated include morphine, buprenorphine, pethidine, tramaldol, metamizole and acetylsalicylacid. They will only be administrated as needed.; Procedure: time interval between ESWL and ERCP is greater than 12h; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful MPD Cannulation Rates	technical success rate of pancreatic cannulation	during ERCP procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	during ERCP procedure
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.	30 days
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.	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment-related costs in RMB from initial enrollment to the end of the study	The total costs in RMB of each hospitalization	through endotherapy completion, an average of 14days
The hospitalization time	Length of hospitalization due to ESWL /ERCP and complications	through endotherapy completion, an average of 14days

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Investigators: Principal Investigator: Zhuan Liao, MD, Changhai Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2025
• Primary Completion (Actual): October 18, 2025
• Study Completion (Actual): October 20, 2025

Study Registration Dates

• First Submitted: January 10, 2022
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (Actual): March 8, 2022

Study Record Updates

• Last Update Posted (Estimated): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Chronic pancreatitis; Endoscopic Retrograde Cholangiopancreatography(ERCP); Extracorporeal Shock Wave Lithotripsy(ESWL); Pancreatic stones
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Digestive System Diseases; Pancreatic Diseases; Pathological Conditions, Signs and Symptoms; Pancreatitis; Pancreatitis, Chronic; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Azoles; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Piperidines; Diagnostic Techniques, Surgical; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Digestive System Surgical Procedures; Diagnostic Imaging; Heterocyclic Compounds, 4 or More Rings; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Central Nervous System Agents; Morphine Derivatives; Pyrazoles; Radiography; Acids, Heterocyclic; Pyrazolones; Cholangiography; Radiography, Abdominal; Isonipecotic Acids; Aminopyrine; Morphine; Analgesics; Dipyrone; Meperidine; Buprenorphine; Cholangiopancreatography, Endoscopic Retrograde
• Other Study ID Numbers: Optimal Timing of Endoscopic

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No