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Evaluation of the SpyGlass DS for Detection of Residual Pancreatic Calculations

Primary Purpose

Pancreatitis, Chronic

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
SpyGlass DS
Sponsored by
Hospital St. Joseph, Marseille, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pancreatitis, Chronic

Eligibility Criteria

18 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hopital Saint Jospeh MarseilleRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SpyGlass DS after endoscopic treatment

Arm Description

Outcomes

Primary Outcome Measures

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. .

Secondary Outcome Measures

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.
VAS score for pancreatic pain
pain visual analogue scale from 0 (no pain) to 10 (worst pain possible)
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)
Analgesic consumption
total daily dose (mg)
Rate of patients hospitalized for pancreatic pain
Rate of operated patients requiring partial / total pancreatectomy, or pancreas-jejunal shunts for pancreatic pain
Rate of patients requiring endoscopic treatment (placement of pancreatic-duct stent, extraction of pancreatic stones)
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.
AE rate and type

Full Information

First Posted
December 11, 2020
Last Updated
July 23, 2021
Sponsor
Hospital St. Joseph, Marseille, France
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1. Study Identification

Unique Protocol Identification Number
NCT04672642
Brief Title
Evaluation of the SpyGlass DS for Detection of Residual Pancreatic Calculations
Official Title
Evaluation of the SpyGlass DS vs Standard Method for Detection of Residual Pancreatic Calculations After Endoscopic Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2021 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital St. Joseph, Marseille, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis, Chronic

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SpyGlass DS after endoscopic treatment
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
SpyGlass DS
Intervention Description
Detection by the SpyGlass DS of residual pancreatic stones not detected by the standard method (CT scan and ERCP)
Primary Outcome Measure Information:
Title
Residual pancreatic stones detected by the Spyglass DS
Description
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 Outcome Measure Information:
Title
Residual pancreatic stones extracted by the SpyGlass DS accessory (the SpyGlass Basket)
Description
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
Title
VAS score for pancreatic pain
Description
pain visual analogue scale from 0 (no pain) to 10 (worst pain possible)
Time Frame
preoperative, 1 month, 6 months and 12 months
Title
Analgesic consumption
Description
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
Title
Analgesic consumption
Description
total daily dose (mg)
Time Frame
preoperative, 1 month, 6 months and 12 months
Title
Rate of patients hospitalized for pancreatic pain
Time Frame
12 months
Title
Rate of operated patients requiring partial / total pancreatectomy, or pancreas-jejunal shunts for pancreatic pain
Time Frame
12 months
Title
Rate of patients requiring endoscopic treatment (placement of pancreatic-duct stent, extraction of pancreatic stones)
Time Frame
12 months
Title
Self-administered quality of life questionnaire score
Description
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.
Time Frame
preoperative, 1 month, 6 months and 12 months
Title
AE rate and type
Time Frame
during and immediately after the operation, 7 days, 1 month, 6 months and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cécile Bielmann
Phone
0033488731070
Email
cbielmann@hopital-saint-joseph.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Rahamia Ahamada
Phone
0033488731071
Email
rahamada@hopital-saint-joseph.fr
Facility Information:
Facility Name
Hopital Saint Jospeh Marseille
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cécile Bielmann
Email
cbielmann@hopital-saint-joseph.fr
First Name & Middle Initial & Last Name & Degree
Arthur LAQUIERE, Md

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the SpyGlass DS for Detection of Residual Pancreatic Calculations

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