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Acute Calculous CholecystitisNCT01894321

The Clinical Outcomes of the Percutaneous Cholecystostomy, Supportive Care Versus Cholecystectomy.

An observational study of Acute Calculous Cholecystitis and Acute Acalculous Cholecystitis, run by Cheju Halla General Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Percutaneous cholecystostomy (PC) is an effective treatment for cholecystitis in surgical high risk patients. However, there has been no definite agreement of the additional cholecystectomy in these patients. The investigators surveyed the clinical outcomes of the PC in surgical high risk patients. Read more about this study

Who is it for?
Any age
How many people
82 participants
Where
1 siteSouth Korea
Study dates
Jan 2007to Dec 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: From November 2007 to November 2012, patients admitted with acute cholecystitis through emergency center or out-patient clinic then underwent ultrasonography guided percutaneous cholecystostomy in Cheju Halla General Hospital were enrolled consecutively.

Who may be able to join

  • Clinical diagnosis of acute cholecystitis
  • Underwent the ultrasound-guided percutaneous cholecystostomy

Who cannot join

  • Transferred patients from other institute after cholecystostomy procedure.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Digestive disease center, Department of Internal Medicine, Cheju Halla General Hospital

    Jeju City, Jeju Special Self-governing Province, 690-766

Other trials in South Korea

About this study

Official title: The Percutaneous Cholecystostomy is Appropriate as the Ultimate Treatment of Acute Cholecystitis in Critically Ill Patients: a Cross-sectional Study at Single Center.

Percutaneous cholecystostomy (PC) is an effective treatment for cholecystitis in surgical high risk patients. However, there has been no definite agreement of the additional cholecystectomy in these patients. The investigators surveyed the clinical outcomes of the PC in surgical high risk patients. And the investigators tried to prove the PC can be appropriate and ultimate treatment for acute cholecystitis patients with critical illness through this study.

Read the detailed description

Between 2007 and 2012, all patients admitted for acute cholecystitis, and then underwent ultrasonography guided percutaneous cholecystostomy in Cheju Halla General Hospital were consecutively enrolled.

Among 82 patients, 35 were performed laparoscopic cholecystectomy after recovery (Cholecystectomy group) and 47 treated by best supportive care without additional surgery (BSC group).

The investigators analyzed their surgical risks and clinical outcomes of both patients retrospectively.

Keywords
Acute cholecystitis, Elderly, Critically ill patients, Surgical high risk, Percutaneous cholecystostomy, Cholecystectomy
Medical subject headings
Cholecystitis, Acute

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All cause mortality

    Measured: within 30 days

Secondary outcomes (2)

  1. Evidence of recurrent cholecystitis or biliary complication

    Acute cholecysitits : fever, abdominal pain, abnormal chemistry results Biliary complication : Gallstone pancreatitis, gallstone ileus or cholangitis

    Measured: Within 30 days

  2. Evidence of recurrent cholecystitis or biliary complication

    Acute cholecystits : fever, abdominal pain, abnormal chemistry results Biliary complication : Gallstone pancreatitis, gallstone ileus or cholangitis

    Measured: Within 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2013 (estimated)
  2. Study startJan 2007
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01894321
Sponsor's protocol ID
PTGBD1
Status last verified
Jul 2013
First submitted
29 Jun 2013
Last updated
10 Jul 2013
Results posted
No
Data monitoring committee
No

Publications

  • Everhart JE, Khare M, Hill M, Maurer KR. Prevalence and ethnic differences in gallbladder disease in the United States. Gastroenterology. 1999 Sep;117(3):632-9. doi: 10.1016/s0016-5085(99)70456-7.

    PubMed 10464139

  • Kalliafas S, Ziegler DW, Flancbaum L, Choban PS. Acute acalculous cholecystitis: incidence, risk factors, diagnosis, and outcome. Am Surg. 1998 May;64(5):471-5.

    PubMed 9585788

  • Kiviluoto T, Siren J, Luukkonen P, Kivilaakso E. Randomised trial of laparoscopic versus open cholecystectomy for acute and gangrenous cholecystitis. Lancet. 1998 Jan 31;351(9099):321-5. doi: 10.1016/S0140-6736(97)08447-X.

    PubMed 9652612

  • Lo CM, Liu CL, Fan ST, Lai EC, Wong J. Prospective randomized study of early versus delayed laparoscopic cholecystectomy for acute cholecystitis. Ann Surg. 1998 Apr;227(4):461-7. doi: 10.1097/00000658-199804000-00001.

    PubMed 9563529

  • Koo KP, Thirlby RC. Laparoscopic cholecystectomy in acute cholecystitis. What is the optimal timing for operation? Arch Surg. 1996 May;131(5):540-4; discussion 544-5. doi: 10.1001/archsurg.1996.01430170086016.

    PubMed 8624202

  • Lujan JA, Parrilla P, Robles R, Marin P, Torralba JA, Garcia-Ayllon J. Laparoscopic cholecystectomy vs open cholecystectomy in the treatment of acute cholecystitis: a prospective study. Arch Surg. 1998 Feb;133(2):173-5. doi: 10.1001/archsurg.133.2.173.

    PubMed 9484730

  • Houghton PW, Jenkinson LR, Donaldson LA. Cholecystectomy in the elderly: a prospective study. Br J Surg. 1985 Mar;72(3):220-2. doi: 10.1002/bjs.1800720327.

    PubMed 3978383

  • Frazee RC, Nagorney DM, Mucha P Jr. Acute acalculous cholecystitis. Mayo Clin Proc. 1989 Feb;64(2):163-7. doi: 10.1016/s0025-6196(12)65670-5.

    PubMed 2921875

  • Weiss CA 3rd, Lakshman TV, Schwartz RW. Current diagnosis and treatment of cholecystitis. Curr Surg. 2002 Jan-Feb;59(1):51-4. doi: 10.1016/s0149-7944(01)00628-6. No abstract available.

    PubMed 16093104

  • Vogelzang RL, Nemcek AA Jr. Percutaneous cholecystostomy: diagnostic and therapeutic efficacy. Radiology. 1988 Jul;168(1):29-34. doi: 10.1148/radiology.168.1.3289094.

    PubMed 3289094

  • Hultman CS, Herbst CA, McCall JM, Mauro MA. The efficacy of percutaneous cholecystostomy in critically ill patients. Am Surg. 1996 Apr;62(4):263-9.

    PubMed 8600844

  • Welschbillig-Meunier K, Pessaux P, Lebigot J, Lermite E, Aube Ch, Brehant O, Hamy A, Arnaud JP. Percutaneous cholecystostomy for high-risk patients with acute cholecystitis. Surg Endosc. 2005 Sep;19(9):1256-9. doi: 10.1007/s00464-004-2248-6. Epub 2005 Jul 14.

    PubMed 16132331

  • Byrne MF, Suhocki P, Mitchell RM, Pappas TN, Stiffler HL, Jowell PS, Branch MS, Baillie J. Percutaneous cholecystostomy in patients with acute cholecystitis: experience of 45 patients at a US referral center. J Am Coll Surg. 2003 Aug;197(2):206-11. doi: 10.1016/S1072-7515(03)00143-1.

    PubMed 12892798

  • Hirota M, Takada T, Kawarada Y, Nimura Y, Miura F, Hirata K, Mayumi T, Yoshida M, Strasberg S, Pitt H, Gadacz TR, de Santibanes E, Gouma DJ, Solomkin JS, Belghiti J, Neuhaus H, Buchler MW, Fan ST, Ker CG, Padbury RT, Liau KH, Hilvano SC, Belli G, Windsor JA, Dervenis C. Diagnostic criteria and severity assessment of acute cholecystitis: Tokyo Guidelines. J Hepatobiliary Pancreat Surg. 2007;14(1):78-82. doi: 10.1007/s00534-006-1159-4. Epub 2007 Jan 30.

    PubMed 17252300

  • Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. No abstract available.

    PubMed 7165009

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Calculous Cholecystitis and Acute Acalculous Cholecystitis, run by Cheju Halla General Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All cause mortality (time frame: within 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01894321, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2013.

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