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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SpyGlass DS after endoscopic treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SpyGlass DS | Device | Detection by the SpyGlass DS of residual pancreatic stones not detected by the standard method (CT scan and ERCP) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Saint Jospeh Marseille | Marseille | France |
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| ID | Term |
|---|---|
| D050500 | Pancreatitis, Chronic |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
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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 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |