Clinical trial NCT05270434: Optimal Timing of Endoscopic Intervention in the Treatment of Chronic Pancreatitis.
Official title: Optimal Timing of Endoscopic Intervention After Extracorporeal Shock-Wave Lithotripsy in the Treatment of Chronic Pancreatitis With Pancreatic Stones.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pancreatitis, Chronic
Keywords: Extracorporeal Shock Wave Lithotripsy(ESWL)
Chronic pancreatitis
Endoscopic Retrograde Cholangiopancreatography(ERCP)
Pancreatic stones
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Successful MPD Cannulation Rates
timeFrame: during ERCP procedure
Secondary outcomes:
measure: Successful clearance of MPD stones
timeFrame: during ERCP procedure
measure: post-ERCP complications
timeFrame: 30 days
measure: severity of post-ERCP complications
timeFrame: 30 days
Other outcomes:
measure: Treatment-related costs in RMB from initial enrollment to the end of the study
timeFrame: through endotherapy completion, an average of 14days
measure: The hospitalization time
timeFrame: through endotherapy completion, an average of 14days
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
Study officials:
affiliation: Changhai Hospital
name: Zhuan Liao, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.