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

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

Sponsors

Lead Sponsor: Methodist Health System

Source Methodist Health System
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.

Overall Status Recruiting
Start Date November 8, 2019
Completion Date November 2021
Primary Completion Date November 2021
Study Type Observational
Primary Outcome
Measure Time Frame
Incidence of post-operative complications and mortality oct 2019 - sept 2021
Enrollment 500
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Subtotal cholecystectomy

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

Eligibility

Sampling Method: Non-Probability Sample

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Michal Truitt, MD Principal Investigator Methodist Dallas Medical Center
Overall Contact

Last Name: Crystee Cooper, DHEd

Phone: 214-947-1280

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Methodist Dallas Medical Center Crystee Cooper, DHEd 214-947-1280 [email protected]
Location Countries

United States

Verification Date

November 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Patient Data Undecided
Study Design Info

Observational Model: Case-Only

Time Perspective: Prospective

Source: ClinicalTrials.gov