Evaluation of the SpyGlass DS for Detection of Residual Pancreatic Calculations

Not Applicable

• Conditions: Pancreatitis, Chronic

• Registration Number: NCT04672642
• Lead Sponsor: Hospital St. Joseph, Marseille, France

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-11
• Study First Submitted QC: 2020-12-16
• Study First Posted: 2020-12-17
• Status Verified: 2021-07
• Study Start: 2021-07-12
• Last Update Submitted: 2021-07-23
• Last Update Posted: 2021-07-26
• Primary Completion: 2024-07
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Residual pancreatic stones detected by the Spyglass DS	baseline	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. .

Secondary Outcome Measures

Name	Time	Method
VAS score for pancreatic pain	preoperative, 1 month, 6 months and 12 months	pain visual analogue scale from 0 (no pain) to 10 (worst pain possible)
Residual pancreatic stones extracted by the SpyGlass DS accessory (the SpyGlass Basket)	baseline	rate of residual pancreatic stones extracted by by the SpyGlass DS accessory (the SpyGlass Basket) after being detected by the SpyGlass DS.
Rate of patients hospitalized for pancreatic pain	12 months
Rate of operated patients requiring partial / total pancreatectomy, or pancreas-jejunal shunts for pancreatic pain	12 months
Analgesic consumption	preoperative, 1 month, 6 months and 12 months	total daily dose (mg)
Rate of patients requiring endoscopic treatment (placement of pancreatic-duct stent, extraction of pancreatic stones)	12 months
Self-administered quality of life questionnaire score	preoperative, 1 month, 6 months and 12 months	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.
AE rate and type	during and immediately after the operation, 7 days, 1 month, 6 months and 12 months

Trial Locations

Locations (1)

Hopital Saint Jospeh Marseille; 🇫🇷 Marseille, France