Pancreatitis, Chronic
Conditions
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.
Interventions
DEVICESpyGlass DS
Detection by the SpyGlass DS of residual pancreatic stones not detected by the standard method (CT scan and ERCP)
Sponsors
Hospital St. Joseph, Marseille, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Months to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Analgesic consumption | preoperative, 1 month, 6 months and 12 months | level of analgesic (if several analgesics of different levels are used, the analgesic of the highest level will be taken into account each time) |
| Rate of patients hospitalized for pancreatic pain | 12 months | — |
| 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 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 | — |
| Rate of operated patients requiring partial / total pancreatectomy, or pancreas-jejunal shunts for pancreatic pain | 12 months | — |
Countries
France
Outcome results
None listed