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

NCT ID: NCT05270434

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-12
• Study Completion Date: 2025-10-20

Brief Summary

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

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.

Conditions

Pancreatitis, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

time interval between ESWL and ERCP is 12h

Intervention Type: PROCEDURE

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

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

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

time interval between ESWL and ERCP is greater than 12h

Intervention Type: PROCEDURE

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)

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

Other Intervention Names

ESWL; ERCP; ESWL; ERCP

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changhai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhuan Liao

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhuan Liao, MD

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Locations

Changhai Hospital

Shanghai, , China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 33939679 (View on PubMed)

Other Identifiers

Optimal Timing of Endoscopic

Identifier Type: -

Identifier Source: org_study_id