Evaluation of the SpyGlass DS for Detection of Residual Pancreatic Calculations

Pancreatitis, Chronic Clinical Trial

Official title:

Evaluation of the SpyGlass DS vs Standard Method for Detection of Residual Pancreatic Calculations After Endoscopic Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04672642
• Other study ID #: SPY PCC 2020
• Status: Recruiting
• Phase: N/A
• Start date: July 12, 2021
• Est. completion date: July 2024

Study information

• Verified date: July 2021
• Source: Hospital St. Joseph, Marseille, France
• Contact: Cécile Bielmann
• Phone: 0033488731070
• Email: cbielmann[@]hopital-saint-joseph.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to assess the efficacy of the SpyGlass DS for the detection of residual pancreatic calculations after endoscopic treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months and older

Eligibility

Inclusion Criteria:

• aged 18 and over;
• with chronic calcifying pancreatitis;
• having already received endoscopic treatment for pancreatic pain related to stenosis and / or pancreatic stones;
• having given free, informed and written consent;
• being affiliated to a social security scheme or beneficiary of such a scheme.

Exclusion Criteria:

• contraindications to performing an upper digestive endoscopy;
• haemorrhagic disease, haemostasis and coagulation disorder (PR <60%, PTT> 40 s and platelets <60,000 / mm3;
• pregnant or breastfeeding woman;
• adult patient protected (guardianship or curatorship), or deprived of liberty by a judicial or administrative decision;
• person subject to a safeguard measure.

Related Conditions & MeSH terms

• Pancreatitis
• Pancreatitis, Chronic

Intervention

Device:
• SpyGlass DS
Detection by the SpyGlass DS of residual pancreatic stones not detected by the standard method (CT scan and ERCP)

Locations

Country	Name	City	State
France	Hopital Saint Jospeh Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Hospital St. Joseph, Marseille, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Residual pancreatic stones detected by the Spyglass DS	rate of residual pancreatic stones detected by the SpyGlass DS, after a treatment by CT-scan and ERCP (recommended standard method) showing no stones in the Wirsung's duct. .	baseline
Secondary	Residual pancreatic stones extracted by the SpyGlass DS accessory (the SpyGlass Basket)	rate of residual pancreatic stones extracted by by the SpyGlass DS accessory (the SpyGlass Basket) after being detected by the SpyGlass DS.	baseline
Secondary	VAS score for pancreatic pain	pain visual analogue scale from 0 (no pain) to 10 (worst pain possible)	preoperative, 1 month, 6 months and 12 months
Secondary	Analgesic consumption	level of analgesic (if several analgesics of different levels are used, the analgesic of the highest level will be taken into account each time)	preoperative, 1 month, 6 months and 12 months
Secondary	Analgesic consumption	total daily dose (mg)	preoperative, 1 month, 6 months and 12 months
Secondary	Rate of patients hospitalized for pancreatic pain		12 months
Secondary	Rate of operated patients requiring partial / total pancreatectomy, or pancreas-jejunal shunts for pancreatic pain		12 months
Secondary	Rate of patients requiring endoscopic treatment (placement of pancreatic-duct stent, extraction of pancreatic stones)		12 months
Secondary	Self-administered quality of life questionnaire score	36-Item Short Form Health Survey (SF-36). SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. A score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	preoperative, 1 month, 6 months and 12 months
Secondary	AE rate and type		during and immediately after the operation, 7 days, 1 month, 6 months and 12 months