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Subtotal CholecystectomyNCT04181801

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

An observational study of Subtotal Cholecystectomy and Complicated Acute Cholecystitis, run by Methodist Health System at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Subtotal cholecystectomy
Type of treatment
Surgery or procedure
How many people
500 participants
Where
1 siteUnited States
Study dates
8 Nov 2019to Nov 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Pregnant patients
  • Prior history of subtotal cholecystectomy
  • Percutaneous cholecystostomy tube in place
  • Preoperative diagnosis other than acute cholecystitis
  • Symptomatic cholelithiasis
  • Gallstone pancreatitis
Show all 9Show fewer
  • Choledocholithiasis
  • Malignant/benign tumor
  • Others

Trial locations and contacts

1 site in 1 country.

Crystee Cooper, DHEd contact

214-947-1280

clinicalresearch@mhd.com

Zaid L Haddadin, MEd contact

214-947-1280

clinicalresearch@mhd.com

United States1 site, 1 recruiting
  • Methodist Dallas Medical Center

    Dallas, Texas, 75203

    Crystee Cooper, DHEd, 214-947-1280, clinicalresearch@mhd.com

    Zaid Haddadin, MS, (214) 947-1280, clinicalresearch@mhd.com

    Recruiting

Other trials in United States

About this 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.

Read the 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.

Being tested
Subtotal cholecystectomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Subtotal cholecystectomyProcedure or surgery

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of post-operative complications and mortality

    Incidence of post-operative complications and mortality

    Measured: oct 2019 - sept 2021

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2019
  2. Study start8 Nov 2019
  3. Primary completionNov 2022 (estimated)
  4. Study completionNov 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04181801
Sponsor's protocol ID
052.GME.2019.D
Status last verified
Feb 2022
First submitted
27 Nov 2019
Last updated
25 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Subtotal Cholecystectomy and Complicated Acute Cholecystitis, run by Methodist Health System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Crystee Cooper, DHEd (214-947-1280, clinicalresearch@mhd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of post-operative complications and mortality (time frame: oct 2019 - sept 2021). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2022.

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