Endoscopic Nasogallbladder Drainage Versus Gallbladder Stenting Before Cholecystecomy

Brief Title

Endoscopic Nasogallbladder Drainage Versus Gallbladder Stenting Before Cholecystecomy

Official 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

Brief Summary

      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.
    

Study Type

Interventional

Primary Outcome

Techncal success rate

Secondary Outcome

 Clinical success rate

Condition

Cholecystitis, Acute

Intervention

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

Study Arms / Comparison Groups

 Endoscopic nasogallbladder drainage

Description:  If GB cannulation was achieved and the wire was coiled in the GB, 5 to 7-Fr Pigtail type naso-cholecystic drainage tube (Liguory nasal biliary drainage set; Wilson-Cook Medical, Salem, NC, USA) was placed into the GB

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Device

Estimated Enrollment

35

Start Date

July 2011

Completion Date

December 2014

Primary Completion Date

December 2014

Eligibility Criteria

        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
      

Gender

All

Ages

20 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Byung Moo Yoo, MD, , 

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

NCT ID

NCT02394327

Organization ID

AJIRB-MED-MDB-11-318

Responsible Party

Principal Investigator

Study Sponsor

Ajou University School of Medicine

Study Sponsor

Byung Moo Yoo, MD, Study Director, Ajou University School of Medicine

Verification Date

January 2016