Acute Cholecystitis, Laparoscopic Cholecystectomy, Percutaneous Cholecystostomy
Conditions
Keywords
Acute cholecystitis, Percutaneous cholecystostomy, Laparoscopic cholecystectomy, Early LC, Delay LC
Brief summary
Abstract: Acute cholecystitis (AC) is typically managed according to the 2018 Tokyo Guidelines, with treatment strategies determined by the severity of the disease, patient comorbidities, and hospital capabilities. In cases of moderate AC, treatment options include antibiotics with delayed laparoscopic cholecystectomy (LC), antibiotics with early LC, or antibiotics with percutaneous cholecystostomy (PCC) followed by delayed LC. However, the Toyo Guideline 2018 suggested that there is a lack of consensus regarding the optimal timing for surgery following PCC due to insufficient scientific evidence. In practice, delayed LC is often performed approximately 6 weeks after PCC insertion. While PCC can serve as a treatment option before definite surgery, complications such as tube dislodgment, obstruction, and failure to ambulate are common, leading to further hospital admissions and increased comorbidities. The ESCAPE trial was conducted to evaluate the optimal timing for LC following PCC in moderate and severe forms of acute cholecystitis, with the goal of improving treatment standards and reducing complications associated with PCC retention. We hypothesize that early LC after PCC insertion will be a feasible and effective alternative. Methods: This prospective, randomized controlled trial enrolled patients diagnosed with moderate to severe acute cholecystitis who underwent PCC. Clinical manifestations and laboratory parameters were monitored for 72 hours following PCC insertion. Patients demonstrating clinical or laboratory improvement were subsequently randomized into two groups: early LC and delayed LC. * Early LC group: Laparoscopic cholecystectomy was performed during the same hospitalization. * Delayed LC group: Laparoscopic cholecystectomy was performed more than 6 weeks after PCC insertion. The primary endpoint/outcome is comprehensive complication index (CCI) from PCC and LC. Secondary endpoints include Nasaar Difficulty Scoring, length of hospital stay, rate of subtotal cholecystectomy, rate of conversion to open cholecystectomy and incidence of bile duct injury. Results and Discussion: The results of this study will provide valuable insights into the timing of LC following PCC and may influence future treatment protocols for moderate and severe acute cholecystitis. By assessing the feasibility and safety of early LC after PCC insertion, the ESCAPE trial aims to reduce the burden of PCC-related complications and optimize patient outcomes.
Interventions
PROCEDURELaparoscopic cholecystectomy
Laparoscopic cholecystectomy is the definite treatment for acute cholecystitis. According to Tokyo Guideline 2018, the proper timing of delay LC remains unclear due to lack to proper evidence.
Sponsors
Chiang Mai University
Lampang Hospital
Phrae Hospital
Maharaj Nakorn Chiang Mai Hospital
Yada Suwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patients are diagnosed moderate or severe from of acute cholecystitis according to Tokyo Guideline 2018. * PCC insertion was performed by body interventionists or surgeons. * Laparoscopic cholecystectomy will be performed in Maharaj Nakorn Chiang Mai Hospital, Lampang Hospital and Phrae Hospital. * Age equal or more than 20 years-old
Exclusion criteria
* The patients that suspected CBD stone and need to undergo EUS / ERCP. * Coincidence perihepatic abscess or liver abscess * The patients with active or severe underlying disease, whom specialists suggest to postpone an operation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comprehensive Complication Index from PCC and LC | From enrollment to 3 months postoperative | Comprehensive Complication Index (CCI)is a score derived from Clavien-Dindo Classification. In this study, the complications include both from Percutaneous Cholecystostomy (PCC) and from Laparoscopic Cholecystectomy (LC). The Clavien-Dindo Classification is ranging from 1 (any deviation from postoperative course) to 5 (death). CCI integrates all CD complications and weights its severity. CCI is ranging from 0 (no complication) to 100 (death). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nasaar Difficulty Scoring | During the operation | Nasaar Difficulty Scoring is used to evaluate intraoperative finding of LC difficulty, determining by the surgeons who perform LC. The scores include 3 aspects; gallbladder, cystic pedicle and adhesion. In each aspect, the score is ranging from 1 (the easiest) to 4 (the hardest). |
| Length of Hospital Stay (LOS) | During enrollment to 3 months postoperative or date that complication resolves | In the early LC group, LOS refers to the duration that the patients stays in the hospital for the treatment for acute cholecystitis. In the delay LC group, LOS refers to duration of the first admission (admit for PCC insertion), the admission for LC and other admissions that are associated with PCC retention or LC complication. |
| Rate of Conversion to Open Cholecystectomy | During the operation | — |
| Rate of Subtotal Cholecystectomy | During the operation | — |
| Incidence of Bile Duct Injury | During the operation to 3 months postoperative | — |
Countries
Thailand
Contacts
Primary ContactYada Suwan, Doctor of Medicine
Outcome results
None listed