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Completed

NCT Number: NCT02394327

Endoscopic Nasogallbladder Drainage Versus Gallbladder Stenting Before Cholecystecomy

Early laparoscopic cholecystectomy is the current standard therapy for acute cholecystitis, but temporary decompression of the gallbladder (GB) through percutaneous or endoscopic route can be required to alleviate inflammatory process and reach an appropriate time for elective surgery in patients with high operative risk or marked local inflammation or organ dysfunction. Also preoperative endoscopic retrograde cholangiopancreatography (ERCP) is often needed because common bile duct (CBD) stone is accompanied in patients with acute cholecystitis at reported rate from 7-20%.

Two-steps approach of percutaneous transhepatic GB drainage (PTGBD) followed by ERCP or vice versa has been performed for the treatment of acute cholecystitis with concomitant CBD stone who are not suitable for urgent cholecystectomy. However single-step drainage of CBD and GB through ERCP and endoscopic transpapillary GB drainage (ETGD) using nasocystic tube or plastic stent has alternatively been attempted in patients who have contraindications for PTGBD. In clinical practice, many endoscopists have hesitated to perform ETGD because of its relatively low technical success rate and specific concern about post-ERCP adverse event but it minimizes catheter keeping duration, and provides effective clinical improvement via physiologic route.

Currently there are scarce data on if ETGD using nasocystic tube or plastic stent are comparable in terms of clinical efficacy and safety.

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Key information

Conditions

Cholecystitis, Acute Biliary Tract Diseases Calculi Cholecystitis Cholecystolithiasis Cholelithiasis Common Bile Duct Calculi Digestive System Diseases Gallbladder Diseases Gallstones Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ajou University Hospital

Suwon, Gyeonggido, 443-380, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • grade II or III acute cholecystitis met Tokyo 13 diagnostic criteria
  • a high suspicion of CBD stone based on laboratory and imaging study
  • informed consent given.

Exclusion criteria

  • bilo-pancreatic malignancy or surgically altered enteric anatomy
  • subsequent elective surgery is expected to be impossible even after GB decompression based on American Society of Anesthesiologist class

Treatment and study plan

7-Fr Pigtail type naso-cholecystic drainage tube (Liguory nasal biliary drainage set; Wilson-Cook Medical, Salem, NC, USA)

Device

Endoscopic

7-Fr double pigtail plastic stent (Zimmon; Wilson-Cook Medical, Salem, NC, USA)

Device

Primary outcomes

  1. Techncal success rate

    Time frame: From the time of randomization until the time when the endoscopic procedure is ended, assessed up to 24hours

    This outcome was defined as successful deep GB cannulation and placement of assigned drainage device by randomization, and determined by the operator based on the fluoroscoic images of the procedures.

Secondary outcomes

  1. Clinical success rate

    Time frame: From the date of randomization until the date of clinical improvement (fever, leukocytosis, abdominal pain), assessed up to 72 hours

    This outcome was defined as improvement of three clinical parameters of acute cholecystitis (fever, abdominal pain, leukocytosis) within 72 hours following either type of ETGD procedure, and assessed by the review of patient's mediacal records.

  2. early adverse event

    Time frame: From the date of the randomization until the date of the elective cholecystectomy, assessed up to 2 weeks

    This outcome was defined as any procedure related event occurring between the endoscopic procedure and elective cholecystectomy, and assessed by the patient's medical records.

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Official study title

Endoscopic Naso-gallbladder Drainage Versus Gallbladder Stenting Before Elective Cholecystectomy in Patients With Acute Cholecystitis and a High Suspicion of Common Bile Duct Stone; A Prospective Randomized Preliminary Study

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Mar 20, 2015
Registry last updated
Jan 5, 2016

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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