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

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.

Study Overview

• Status: Recruiting
• Conditions: Subtotal Cholecystectomy; Complicated Acute Cholecystitis
• Intervention / Treatment: Procedure: Subtotal 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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Zaid L Haddadin, MEd; Phone Number: 214-947-1280; Email: clinicalresearch@mhd.com

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75203
      • Recruiting
      • Methodist Dallas Medical Center
      • Contact: Zaid Haddadin, MS; Phone Number: (214) 947-1280; Email: ClinicalResearch@mhd.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All eligible cholecystectomy cases from October 2019 to October 2020 at MDMC will be enrolled.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of post-operative complications and mortality	Incidence of post-operative complications and mortality	oct 2019 - sept 2021

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Michal Truitt, MD, Methodist Dallas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2019
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: November 27, 2019
• First Submitted That Met QC Criteria: November 27, 2019
• First Posted (Actual): November 29, 2019

Study Record Updates

• Last Update Posted (Actual): February 25, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gallbladder Diseases; Biliary Tract Diseases; Cholecystitis; Acalculous Cholecystitis; Cholecystitis, Acute
• Other Study ID Numbers: 052.GME.2019.D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No