Treatment Strategy of Pancreatic Radiolucent Stone

• ClinicalTrials.gov Identifier: NCT04628273
• Recruitment Status: Completed
• First Posted: November 13, 2020
• Last Update Posted: December 2, 2020
• Sponsor: Changhai Hospital
• Information provided by (Responsible Party): Zhaoshen Li, Changhai Hospital

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Chronic Pancreatitis	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 Design

• Study Type: Observational
• Actual Enrollment: 52 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Prospective Cohort Study of Large Pancreatic Radiolucent Stone
• Actual Study Start Date: March 1, 2011
• Actual Primary Completion Date: December 30, 2018
• Actual Study Completion Date: January 30, 2020

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. rate of pain relief [ Time Frame: after treatment to 2020-01-30 ]
   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%)

Secondary Outcome Measures :

1. rate of stone clearance [ Time Frame: during ERCP procedure ]
   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
2. score of life quality [ Time Frame: after treatment to 2020-01-30 ]
   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

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

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. Review.

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.

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.

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.

• Responsible Party: Zhaoshen Li, Director of Gastroenterology，Changhai Hospital；Academician of Chinese Academy of Engineering, Changhai Hospital
• ClinicalTrials.gov Identifier: NCT04628273
• Other Study ID Numbers: Large PRS
• First Posted: November 13, 2020
• Last Update Posted: December 2, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pancreatitis; Pancreatitis, Chronic; Pancreatic Diseases; Digestive System Diseases