Clinical trial NCT04181801: Subtotal Cholecystectomy for Complicated Acute Cholecystitis: a Multicenter Prospective Observational Study
Official title: Subtotal Cholecystectomy for Complicated Acute Cholecystitis: a Multicenter Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Subtotal Cholecystectomy
Complicated Acute Cholecystitis
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2019-11-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible cholecystectomy cases from October 2019 to October 2020 at MDMC will be enrolled.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of post-operative complications and mortality
timeFrame: oct 2019 - sept 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Michal Truitt, MD
role: PRINCIPAL_INVESTIGATOR
References: