Evaluation of the SpyGlass DS for Detection of Residual Pancreatic Calculations

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

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 Overview

• Status: Recruiting
• Conditions: Pancreatitis, Chronic
• Intervention / Treatment: Device: SpyGlass DS

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France
    • Recruiting
    • Hopital Saint Jospeh Marseille
    • Contact: Cécile Bielmann; Email: cbielmann@hopital-saint-joseph.fr
    • Principal Investigator: Arthur LAQUIERE, Md

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SpyGlass DS after endoscopic treatment	Device: SpyGlass DS; Detection by the SpyGlass DS of residual pancreatic stones not detected by the standard method (CT scan and ERCP)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital St. Joseph, Marseille, France

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 12, 2021
• Primary Completion (ANTICIPATED): July 1, 2024
• Study Completion (ANTICIPATED): July 1, 2024

Study Registration Dates

• First Submitted: December 11, 2020
• First Submitted That Met QC Criteria: December 16, 2020
• First Posted (ACTUAL): December 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2021
• Last Update Submitted That Met QC Criteria: July 23, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Pancreatitis, Chronic
• Other Study ID Numbers: SPY PCC 2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No