Evaluation of the SpyGlass DS for Detection of Residual Pancreatic Calculations

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

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

Conditions
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Pancreatitis, Chronic

Intervention / Treatment
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* Device: SpyGlass DS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SpyGlass DS after endoscopic treatment<br> | Device: SpyGlass DS<br>* Detection by the SpyGlass DS of residual pancreatic stones not detected by the standard method (CT scan and ERCP)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Analgesic consumption | total daily dose (mg) | preoperative, 1 month, 6 months and 12 months | 
| 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 | 
| Rate of patients requiring endoscopic treatment (placement of pancreatic-duct stent, extraction of pancreatic stones) |  | 12 months | 
| 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 | 
| AE rate and type |  | during and immediately after the operation, 7 days, 1 month, 6 months and 12 months |