Treatment Strategy of Pancreatic Radiolucent Stone

A Prospective Cohort Study of Large Pancreatic Radiolucent Stone

Treatment strategy of chronic pancreatitis (CP) patients with large pancreatic radiolucent stone (≥ 5mm) has not been established. We aimed to figure out clinical features and efficacy of endotherapy for large pancreatic radiolucent stone.

Study Overview

• Status: Completed
• Conditions: Chronic Pancreatitis
• Intervention / Treatment: Procedure: encoscopic retrograde cholangio-pancreatography, extracorporeal shock wave lithotripsy

Detailed Description

1. Treatment strategy of CP patients with large pancreatic stone：

1. . For patients with large radiolucent stone，ERCP with balloon sphincteroplasty was performed directly to remove radiolucent stone. If ERCP intubation failed, endoscopic ultrasound-guided drainage of pancreatic duct, surgery or medication would be applied. ESWL was performed in the following situations. Frist, MPD strictures was so severe that dilation catheter can not be inserted during ERCP. Second, there was cystic dilatation in MPD and pancreatic radiolucent stone located in cystic dilatation could not be extracted by extraction balloon or basket. In the above cases, the naso-pancreatic catheterwas inserted during ERCP, and then ESWL would be performed with repeated injection of contrast medium. After ESWL, repeated washing and negative pressure drainage were performed, and at last contrast medium was injected again to make sure the stones were cleared. For patients without MPD strictures, the nasopancreatic catheter can be directly removed, otherwise the nasopancreatic duct would be cut off into a stent.
2. . For patients with large radiopaque stone, repeated P-ESWL sessions were performed, and ERCP was routinely performed 48 hours after the last P-ESWL. If ERCP intubation failed, medication or surgery would be recommended.

2. A prospective cohort study was conducted in CP patients with large radiolucent stone. Patients with large radiopaque stone were matched as the control group, with a ratio of 1:2 according to admission time.

3. The primary outcome was pain relief. The secondary outcomes were stone clearance, quality of life score, and changes in pancreatic exocrine and endocrine function.

• Study Type: Observational
• Enrollment (Actual): 52

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

CP patients with pancreatic radiolucent stones large than 5mm from March 2011 to December 2018 admitted to Changhai Hospital were included in this study. Patients with pancreatic radiopaque stones large than 5mm were matched as the control group, with a ratio of 1:2 according to admission time. CP was diagnosed primarily based on the Asia-Pacific consensus. Pancreatic radiopaque stone was diagnosed by CT scan while radiolucent stone by MRI or MRCP.

Description

Inclusion Criteria:

Clinical diagnosis of chronic pancreatitis; With pancreatic radiolucent stones large than 5mm

Exclusion Criteria:

Autoimmune pancreatitis; Groove pancreatitis; Pancreatic cancer diagnosed within 2 years after diagnosis of chronic pancreatitis

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
radiolucent stone group	Procedure: encoscopic retrograde cholangio-pancreatography, extracorporeal shock wave lithotripsy
radiopaque stone group	Procedure: encoscopic retrograde cholangio-pancreatography, extracorporeal shock wave lithotripsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of pain relief	Pain relief is evaluated by Izbicki pain score and classified as complete relief (Izbicki pain score ≤ 10) or partial relief (Izbicki pain score > 10 after a decrease of > 50%)	after treatment to 2020-01-30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of stone clearance	Rate of stone clearance is evaluated by ERCP as follows: a) complete clearance as clearance of > 90% of stone volume; b) partial clearance as clearance of 50%-90% of stone volume; c) unsuccessful clearance as less than 50% clearance of stone volume	during ERCP procedure
score of life quality	Quality of life score was a subjective evaluation index of patient which ranged from 0 to 100, with higher score indicating a better quality of life	after treatment to 2020-01-30

Collaborators and Investigators

• Sponsor: Changhai Hospital

Publications and helpful links

General Publications

• Tandan M, Reddy DN, Santosh D, Vinod K, Ramchandani M, Rajesh G, Rama K, Lakhtakia S, Banerjee R, Pratap N, Venkat Rao G. Extracorporeal shock wave lithotripsy and endotherapy for pancreatic calculi-a large single center experience. Indian J Gastroenterol. 2010 Jul;29(4):143-8. doi: 10.1007/s12664-010-0035-y. Epub 2010 Aug 18.
• Neuhaus H. Fragmentation of pancreatic stones by extracorporeal shock wave lithotripsy. Endoscopy. 1991 May;23(3):161-5. doi: 10.1055/s-2007-1010647. No abstract available.
• Sauerbruch T, Holl J, Sackmann M, Paumgartner G. Extracorporeal lithotripsy of pancreatic stones in patients with chronic pancreatitis and pain: a prospective follow up study. Gut. 1992 Jul;33(7):969-72. doi: 10.1136/gut.33.7.969.
• Delhaye M, Arvanitakis M, Verset G, Cremer M, Deviere J. Long-term clinical outcome after endoscopic pancreatic ductal drainage for patients with painful chronic pancreatitis. Clin Gastroenterol Hepatol. 2004 Dec;2(12):1096-106. doi: 10.1016/s1542-3565(04)00544-0.
• Maydeo A, Bhandari S, Bapat M. Endoscopic balloon sphincteroplasty for extraction of large radiolucent pancreatic duct stones (with videos). Gastrointest Endosc. 2009 Oct;70(4):798-802. doi: 10.1016/j.gie.2009.05.004.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2011
• Primary Completion (ACTUAL): December 30, 2018
• Study Completion (ACTUAL): January 30, 2020

Study Registration Dates

• First Submitted: November 7, 2020
• First Submitted That Met QC Criteria: November 7, 2020
• First Posted (ACTUAL): November 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 2, 2020
• Last Update Submitted That Met QC Criteria: November 30, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Pancreatitis, Chronic
• Other Study ID Numbers: Large PRS

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