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Subtotal Cholecystectomy for Complicated Acute Cholecystitis: a Multicenter Prospective Observational Study

Subtotal Cholecystectomy for Complicated Acute Cholecystitis: a Multicenter Prospective Observational Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04181801
Enrollment
500
Registered
2019-11-29
Start date
2019-11-08
Completion date
2022-11-30
Last updated
2022-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complicated Acute Cholecystitis, Subtotal Cholecystectomy

Brief summary

We believe that subtotal cholecystectomy is a safe alternative to total cholecystectomy when the complicated gallbladder is encountered, resulting in decreased or equivalent risk of bile duct injury, major vascular injury, postoperative hemorrhage, infectious complications, and mortality. Additionally, we hope to further elucidate the expected outcomes of the varying subtypes of subtotal cholecystectomy in order to determine the safest approach, assuring the lowest need for secondary intervention, recurrent biliary disease, or need for a completion cholecystectomy.

Detailed description

The first reported subtotal cholecystectomy occurred in 1955. Additional case reports and studies have been carried out, further defining this terminology as a method of avoiding misidentification injuries of the biliary system or portal vasculature when critical view of safety cannot be safely achieved. Recent data supports the safety of this decision, showing equivalent morbidity rates to total cholecystectomy in a large metanalysis of 1,231 patients. Importantly, only 4 of the 30 included studies were prospective in nature, allowing definition variability and inconsistent reporting of outcomes. Additional reports showed variable data regarding effect on hospital LOS, need for secondary intervention (including endoscopic retrograde cholangiopancreatography (ERCP), percutaneous drainage bilioma, or completion cholecystectomy), infectious complications, biliary or major vascular injury, and mortality. Some studies suggest that while subtotal cholecystectomy is associated with a decreased rate of bile duct injury and a lower conversion to open operation, this comes at the cost of increasing bile leak and recurrent biliary complications. Furthermore, the relatively recent distinction between fenestrating and reconstituting subtypes of subtotal cholecystectomy remain ill-defined in many of these studies, and outcomes between the two modalities remain variable across the literature. There is an obvious need for a head-to-head, prospective comparison between these subtypes to determine the safety and efficacy of the chosen intervention. To determine the impact of these differing techniques for subtotal cholecystectomy (namely reconstituting and fenestrating subtypes) as indicated by Tokyo Criteria (Table 1), for the management of the difficult cholecystectomy on short-term and long-term patient outcomes.

Interventions

PROCEDURESubtotal cholecystectomy

a surgical procedure in which more than the top half of the gallbladder is removed

Sponsors

Methodist Health System
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients ≥ 18 years of age * Preoperative definitive diagnosis of acute cholecystitis (Tokyo guideline: Table 1)

Exclusion criteria

* Pregnant patients * Prior history of subtotal cholecystectomy * Percutaneous cholecystostomy tube in place * Preoperative diagnosis other than acute cholecystitis * Symptomatic cholelithiasis * Gallstone pancreatitis * Choledocholithiasis * Malignant/benign tumor * Others

Design outcomes

Primary

MeasureTime frameDescription
Incidence of post-operative complications and mortalityoct 2019 - sept 2021Incidence of post-operative complications and mortality

Countries

United States

Contacts

Primary ContactCrystee Cooper, DHEd
clinicalresearch@mhd.com214-947-1280
Backup ContactZaid L Haddadin, MEd
clinicalresearch@mhd.com214-947-1280

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026