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

Pancreatitis, Chronic Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05270434
• Other study ID #: Optimal Timing of Endoscopic
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: February 2022
• Source: Changhai Hospital
• Contact: Zhuan Liao
• Phone: 13061921980
• Email: liaozhuan[@]smmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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 three groups, which are divided according to the time interval between ESWL and ERCP, including <12 hours subgroup, 12~36 hours subgroup and >36 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 225
• Est. completion date: February 1, 2023
• Est. primary completion date: January 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatitis
• Pancreatitis, Chronic

Intervention

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.
• time interval between ESWL and ERCP is 12-36h
The patients received intravenous analgesia before the ESWL. After the last ESWL session, the patients are treated with following ERCP within 12-36h.
• time interval between ESWL and ERCP is greater than 36h
The patients received intravenous analgesia before the ESWL. After the last ESWL session, the patients are treated with following ERCP >36h.

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.

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	The hospitalization time	Length of hospitalization due to ESWL /ERCP and complications	through endotherapy completion, an average of 14days
Primary	Successful MPD Cannulation Rates	technical success rate of pancreatic cannulation	during ERCP procedure
Secondary	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
Secondary	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
Secondary	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