Treatment Strategy of Pancreatic Radiolucent Stone

Chronic Pancreatitis Clinical Trial

Official title:

A Prospective Cohort Study of Large Pancreatic Radiolucent Stone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04628273
• Other study ID #: Large PRS
• Status: Completed
• Start date: March 1, 2011
• Est. completion date: January 30, 2020

Study information

• Verified date: November 2020
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: January 30, 2020
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Pancreatitis
• Pancreatitis, Chronic

Intervention

Procedure:
• encoscopic retrograde cholangio-pancreatography, extracorporeal shock wave lithotripsy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

References & Publications (5)

Delhaye M, Arvanitakis M, Verset G, Cremer M, Devière 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. — View Citation

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. — View Citation

Neuhaus H. Fragmentation of pancreatic stones by extracorporeal shock wave lithotripsy. Endoscopy. 1991 May;23(3):161-5. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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