Evaluation of the SpyGlass DS for Detection of Residual Pancreatic Calculations

Hospital St. Joseph, Marseille, France27 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Pancreatitis, Chronic

Interventions

SpyGlass DSDEVICE

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

Eligibility

Sex: ALLMin age: 18 Months

Medical Language ↔ Plain English

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.

Locations (1)

Hopital Saint Jospeh Marseille

Marseille, France

Outcomes

Primary Outcomes

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. .

Time frame: baseline

Secondary Outcomes

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.

Time frame: baseline

VAS score for pancreatic pain

pain visual analogue scale from 0 (no pain) to 10 (worst pain possible)

Time frame: 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)

Time frame: preoperative, 1 month, 6 months and 12 months

Analgesic consumption

total daily dose (mg)

Time frame: preoperative, 1 month, 6 months and 12 months

Rate of patients hospitalized for pancreatic pain

Time frame: 12 months

Rate of operated patients requiring partial / total pancreatectomy, or pancreas-jejunal shunts for pancreatic pain

Time frame: 12 months

Rate of patients requiring endoscopic treatment (placement of pancreatic-duct stent, extraction of pancreatic stones)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.