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Completed

NCT Number: NCT04672642

Evaluation of the SpyGlass DS for Detection of Residual Pancreatic Calculations

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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Key information

Conditions

Pancreatitis, Chronic Chronic Disease Digestive System Diseases Disease Attributes Pancreatic Diseases Pancreatitis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Saint Jospeh Marseille

Marseille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SpyGlass DS

Device

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

Primary outcomes

  1. Residual pancreatic stones detected by the Spyglass DS

    Time frame: 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 outcomes

  1. Residual pancreatic stones extracted by the SpyGlass DS accessory (the SpyGlass Basket)

    Time frame: baseline

    rate of residual pancreatic stones extracted by by the SpyGlass DS accessory (the SpyGlass Basket) after being detected by the SpyGlass DS.

  2. VAS score for pancreatic pain

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

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

  3. Analgesic consumption

    Time frame: 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)

  4. Analgesic consumption

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

    total daily dose (mg)

  5. Rate of patients hospitalized for pancreatic pain

    Time frame: 12 months

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

    Time frame: 12 months

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

    Time frame: 12 months

  8. Self-administered quality of life questionnaire score

    Time frame: 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.

  9. AE rate and type

    Time frame: during and immediately after the operation, 7 days, 1 month, 6 months and 12 months

Sponsors and collaborators

Lead sponsor

Hospital St. Joseph, Marseille, France

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 17, 2020
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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