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Die klinische Studie NCT07495111 für Cholelithiasis Associated With Common Bile Duct Stones ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen.
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Prophylactic PS Placement to Prevent Pancreatitis After Endoscopic Transpapillary GPC for Cholelithiasis With Concomitant Choledocholithiasis 88 Randomisiert

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Die klinische Studie NCT07495111 ist eine interventionsstudie zur Untersuchung von Cholelithiasis Associated With Common Bile Duct Stones und hat den Status offene rekrutierung. Die Studie startete am 1. Dezember 2025 und soll 88 Teilnehmer aufnehmen. Durchgeführt von Qilu Hospital of Shandong University ist der Abschluss für 1. Juni 2028 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 27. März 2026 aktualisiert.
Kurzbeschreibung
In this multicenter, randomized trial, patients with cholelithiasis with concomitant choledocholithiasis based on inclusion and exclusion criteria will be randomly assigned to receive rectal indomethacin alone or the combination of indomethacin plus a prophylactic pancreatic stent after endoscopic transpapillary gallbladder-preserving cholecystolithotomy.Clinical data and patient-reported outcomes are regularly colle...Mehr anzeigen
Offizieller Titel

Prophylactic Pancreatic Stent Placement to Prevent Pancreatitis After Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy for Cholelithiasis With Concomitant Choledocholithiasis

Erkrankungen
Cholelithiasis Associated With Common Bile Duct Stones
Weitere Studien-IDs
  • 2025SDU-QILU-2
NCT-Nummer
NCT07495111
Studienbeginn (tatsächlich)
2025-12-01
Zuletzt aktualisiert
2026-03-27
Studienende (vorauss.)
2028-06
Geplante Rekrutierung
88
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Stichwörter
Cholelithiasis with Concomitant Choledocholithiasis
Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy
post-ERCP pancreatitis
Randomized Controlled Trial (RCT)
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Doppelt verblindet
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
AndereReceive rectal indomethacin alone
rectal indomethacin alone
rectal indomethacin was used alone in the control group
ExperimentellCombination of indomethacin plus a prophylactic pancreatic stent
Prophylactic pancreatic stent
All procedure-related interventions except for the administration of rectal indomethacin and placement of a prophylactic stent were left to the discretion of the endoscopist.During ERCP, once eligibility was confirmed, patients were randomized in a 1:1 ratio to receive a prophylactic stent or not.In patients assigned to the indomethacin plus stent group, endoscopists were expected to attempt stent placement, although...Mehr anzeigen
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
The Proportion of Patients with Post-ERCP Pancreatitis
If a patient exhibits two out of the following three characteristics, a diagnosis of postoperative pancreatitis is made: (1) Abdominal pain consistent with acute pancreatitis, (2) Serum amylase and/or lipase levels at least three times the upper limit of normal, and (3) Abdominal imaging studies showing radiological changes consistent with acute pancreatitis.
24 hours to 72 hours after ERCP
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
The Proportion of Patients with Mild, Moderate or Severe Post-ERCP Pancreatitis
The severity was defined as mild post-ERCP pancreatitis resulting in a hospitalization of ≤3 days, moderate post-ERCP pancreatitis resulting in a hospitalization of 4-10 days, and severe post-ERCP pancreatitis resulting in a hospitalization of \> 10 days, or leading to the development of pancreatic necrosis or pseudocyst, or requiring percutaneous or surgical intervention.
Within 1 months after ERCP
Clinical Success Rate
Complete removal of gallbladder stones.
Within 1 months after ERCP
The Proportion of Patients with Other Complications
Other complications mainly include bleeding, cholangitis, cholecystitis, perforation, hypoxemia, hypotension or hypertension, etc.
Within 6 months after ERCP
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
  1. Patients aged 18 years or older;
  2. Patients with gallbladder stones and common bile duct (CBD) stones confirmed by ultrasound and/or MRCP or other imaging modalities (CT/MRI);
  3. Patients with every gallbladder stone ≤1 cm in diameter or sludge-like stones;
  4. Patients without a history of gastrointestinal reconstruction surgery,cholecystectomy or previous biliary surgery, includes ERCP;
  5. The morphology and size of the gallbladder are essentially normal and the thickness of the gallbladder wall is ≤3 mm;
  6. Patients with at least one of the following high-risk factors for post-ERCP pancreatitis (PEP): suspected sphincter of Oddi dysfunction (SOD), female sex, history of pancreatitis, difficult cannulation (defined as ≥5 cannulation attempts or ≥5 minutes of cannulation time), pancreatic duct contrast injection, age <35 years, non-dilated extrahepatic bile duct, no history of chronic pancreatitis, normal serum bilirubin, precut sphincterotomy, biliary balloon dilation, incomplete bile duct stone clearance, or intraductal ultrasound ;
  7. Patients who voluntarily provide signed informed consent.

  1. Patients with any of the following diagnoses: chronic atrophic cholecystitis, porcelain gallbladder, suspected gallbladder malignancy, or Mirizzi syndrome;
  2. Patients with ectopic duodenal papilla or congenital pancreaticobiliary malformations;
  3. Patients unfit for ERCP endoscopic treatment due to severe systemic diseases;
  4. Patients with severe coagulation dysfunction (defined as an International Normalized Ratio \[INR\] >1.5) or significant thrombocytopenia (platelet count <50×10⁹/L);
  5. Pregnant women;
  6. Patients with guidewire entry into the pancreatic duct ≥3 times during the procedure;
  7. Patients with allergies to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs);
  8. Patients with congenital or acquired absence of the rectum;
  9. Patients with severe acute pancreatitis
Qilu Hospital of Shandong University logoQilu Hospital of Shandong University
Zentrale Studienkontakte
Kontakt: Zhen Li, MD, 18560086106, [email protected]
1 Studienstandorte in 1 Ländern

Shandong

Qilu Hospital of Shandong University, Jinan, Shandong, 250063, China
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