Factors Affecting The Recurrence Of Acute Cholecystitis After Treatment With Percutaneous Cholecystostomy

NCT ID: NCT05525442

Last Updated: 2022-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2022-01-01

Brief Summary

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Percutaneous cholecystostomy is used to reduce the complications and mortality associated with surgery in patients with high surgical risk in acute cholecystitis. Although this method generally acts as a bridge treatment for interval cholecystectomy in patients, interval cholecystectomy is not performed in every patient after percutaneous cholecystostomy. The aim of this study was to determine the recurrence rate of patients who did not have interval cholecystectomy after treatment with percutaneous cholecystostomy and to investigate the factors that may affect the recurrence.

Detailed Description

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Acute cholecystitis is an inflammatory disease of the gallbladder and is often associated with cholelithiasis. According to Tokyo Guide 2018 (TG18), acute cholecystitis is grouped with various risk factors and predictive factors. Early laparoscopic cholecystectomy or late cholecystectomy after medical therapy is recommended for patients with grades 1 and 2. On the other hand, non-operative treatments such as percutaneous cholecystostomy catheter and antibiotic therapy are recommended for selected patients with high surgical risk and serious comorbidities in order to prevent morbidity and mortality. They suggested that percutaneous cholecystostomy catheter could be used as the definitive treatment of acute cholecystitis in these high-risk patients who are not suitable for surgery. Debate continues as to whether cholecystectomy is necessary for these patients. Because studies have shown that the recurrence rate of acute cholecystitis after percutaneous cholecystostomy catheter treatment varies between 4% and 22%. For these reasons, assessing the risk of recurrence of acute cholecystitis in patients initially treated with percutaneous cholecystostomy is essential to aid decision making.

Conditions

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Acute Cholecystitis Percutaneous Cholecystostomy Recurrence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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patients with recurrence

Recurrence in the first year after percutaneous cholecystostomy catheter removal

percutaneous cholecystostomy

Intervention Type PROCEDURE

Transhepatic gallbladder drainage was performed under ultrasound guidance after local anesthesia was administered by interventional radiology to patients with acute cholecystitis. Subsequently, an 8-10 Fr pigtail catheter was inserted into the gallbladder using a guide wire under fluoroscopy.

patients without recurrence

No recurrence within the first year after percutaneous cholecystostomy catheter removal

percutaneous cholecystostomy

Intervention Type PROCEDURE

Transhepatic gallbladder drainage was performed under ultrasound guidance after local anesthesia was administered by interventional radiology to patients with acute cholecystitis. Subsequently, an 8-10 Fr pigtail catheter was inserted into the gallbladder using a guide wire under fluoroscopy.

Interventions

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percutaneous cholecystostomy

Transhepatic gallbladder drainage was performed under ultrasound guidance after local anesthesia was administered by interventional radiology to patients with acute cholecystitis. Subsequently, an 8-10 Fr pigtail catheter was inserted into the gallbladder using a guide wire under fluoroscopy.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with acute cholecystitis on admission to the emergency department
* Patients treated with percutaneous cholecystostomy catheter according to TK18 acute cholecystitis diagnosis and treatment guideline
* Patients older than 18 years
* Patients who can give their own consent

Exclusion Criteria

* Patients with missing data or not followed up regularly
* Patients whose cholecystostomy catheter was removed during the operation or operated within the first year following the catheter extraction
* Patients with choledocholithiasis, abscess secondary to acute cholecystitis, or hepatopancreatobiliary system malignancy
* Patients who are pregnant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tepecik Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Korhan TUNCER

General Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Korhan Tuncer, MD

Role: PRINCIPAL_INVESTIGATOR

Tepecik Training and Research Hospital

References

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Kiriyama S, Kozaka K, Takada T, Strasberg SM, Pitt HA, Gabata T, Hata J, Liau KH, Miura F, Horiguchi A, Liu KH, Su CH, Wada K, Jagannath P, Itoi T, Gouma DJ, Mori Y, Mukai S, Gimenez ME, Huang WS, Kim MH, Okamoto K, Belli G, Dervenis C, Chan ACW, Lau WY, Endo I, Gomi H, Yoshida M, Mayumi T, Baron TH, de Santibanes E, Teoh AYB, Hwang TL, Ker CG, Chen MF, Han HS, Yoon YS, Choi IS, Yoon DS, Higuchi R, Kitano S, Inomata M, Deziel DJ, Jonas E, Hirata K, Sumiyama Y, Inui K, Yamamoto M. Tokyo Guidelines 2018: diagnostic criteria and severity grading of acute cholangitis (with videos). J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):17-30. doi: 10.1002/jhbp.512. Epub 2018 Jan 5.

Reference Type RESULT
PMID: 29032610 (View on PubMed)

Leveau P, Andersson E, Carlgren I, Willner J, Andersson R. Percutaneous cholecystostomy: a bridge to surgery or definite management of acute cholecystitis in high-risk patients? Scand J Gastroenterol. 2008;43(5):593-6. doi: 10.1080/00365520701851673.

Reference Type RESULT
PMID: 18415753 (View on PubMed)

Sanjay P, Mittapalli D, Marioud A, White RD, Ram R, Alijani A. Clinical outcomes of a percutaneous cholecystostomy for acute cholecystitis: a multicentre analysis. HPB (Oxford). 2013 Jul;15(7):511-6. doi: 10.1111/j.1477-2574.2012.00610.x. Epub 2012 Nov 19.

Reference Type RESULT
PMID: 23750493 (View on PubMed)

Li M, Li N, Ji W, Quan Z, Wan X, Wu X, Li J. Percutaneous cholecystostomy is a definitive treatment for acute cholecystitis in elderly high-risk patients. Am Surg. 2013 May;79(5):524-7. doi: 10.1177/000313481307900529.

Reference Type RESULT
PMID: 23635589 (View on PubMed)

Other Identifiers

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2021/05-12

Identifier Type: -

Identifier Source: org_study_id

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