Acute CholecystitisESCAPENCT07161960
Early Versus Delayed Cholecystectomy After Percutaneous Cholecystostomy in Moderate and Severe Cholecystitis (ESCAPE)
A study testing Laparoscopic cholecystectomy in people with Acute Cholecystitis and Percutaneous Cholecystostomy, run by Yada Suwan at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acute Cholecystitis, Percutaneous Cholecystostomy, Laparoscopic Cholecystectomy
- What is being tested?
- Laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jul 2025to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Chiang Mai University 110 Inthawarorot Road, Sri Phum, Mueang, Chiang Mai 50200, Thailand
Chiang Mai, 50200
Yada Suwan, Doctor of Medicine, +66 084-6561191, yada.suwan@cmu.ac.th
About this study
Official title: Early Versus Delayed Cholecystectomy After Percutaneous Drainage in Moderate and Severe Cholecystitis (ESCAPE Trial)
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.
Read more
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.
- Being tested
- Laparoscopic cholecystectomy
- Keywords
- Acute cholecystitis, Percutaneous cholecystostomy, Laparoscopic cholecystectomy, Early LC, Delay LC
- Medical subject headings
- Cholecystitis, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic cholecystectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Early Laparoscopic Cholecystectomy | Experimental | The patients will undergo laparoscopic cholecystectomy (LC) within the same admission of PCC and after PCC for 72 hours, usually not more than 2 weeks. Receives: Procedure: Laparoscopic cholecystectomy |
| Delay Laparoscopic Cholecystectomy | Experimental | The patients will undergo laparoscopic cholecystectomy (LC) after 6 weeks from PCC insertion, avoiding active inflammation and swelling Receives: Procedure: Laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehensive Complication Index from PCC and LC
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).
Measured: From enrollment to 3 months postoperative
Secondary outcomes (5)
Nasaar Difficulty Scoring
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).
Measured: During the operation
Length of Hospital Stay (LOS)
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.
Measured: During enrollment to 3 months postoperative or date that complication resolves
Rate of Conversion to Open Cholecystectomy
Measured: During the operation
Rate of Subtotal Cholecystectomy
Measured: During the operation
Incidence of Bile Duct Injury
Measured: During the operation to 3 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start1 Jul 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute CholecystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yada Suwan
- Sponsor type
- University, hospital or other
- Collaborators
- Chiang Mai University, Lampang Hospital, Phrae Hospital, Maharaj Nakorn Chiang Mai Hospital
- Responsible party
- Sponsor-investigator, Yada Suwan, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161960
- Sponsor's protocol ID
- SUR-2568-0197
- Acronym
- ESCAPE
- Status last verified
- Sep 2025
- First submitted
- 31 Aug 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to the ethic consideration by the committee of Research, Chiang Mai University, the identification and all treatment history will be reached by the researchers, data collectors and analyzers only to keep privacy for the participants.
Publications
Yamazaki S, Shimizu A, Kubota K, Notake T, Yoshizawa T, Masuo H, Sakai H, Hosoda K, Hayashi H, Yasukawa K, Umemura K, Kamachi A, Goto T, Tomida H, Seki H, Shimura M, Soejima Y. Urgent versus elective laparoscopic cholecystectomy following percutaneous transhepatic gallbladder drainage for high-risk grade II acute cholecystitis. Asian J Surg. 2023 Jan;46(1):431-437. doi: 10.1016/j.asjsur.2022.05.046. Epub 2022 May 21.
PubMed 35610148Woodward SG, Rios-Diaz AJ, Zheng R, McPartland C, Tholey R, Tatarian T, Palazzo F. Finding the Most Favorable Timing for Cholecystectomy after Percutaneous Cholecystostomy Tube Placement: An Analysis of Institutional and National Data. J Am Coll Surg. 2021 Jan;232(1):55-64. doi: 10.1016/j.jamcollsurg.2020.10.010. Epub 2020 Oct 21.
PubMed 33098966Okamoto K, Suzuki K, Takada T, Strasberg SM, Asbun HJ, Endo I, Iwashita Y, Hibi T, Pitt HA, Umezawa A, Asai K, Han HS, Hwang TL, Mori Y, Yoon YS, Huang WS, Belli G, Dervenis C, Yokoe M, Kiriyama S, Itoi T, Jagannath P, Garden OJ, Miura F, Nakamura M, Horiguchi A, Wakabayashi G, Cherqui D, de Santibanes E, Shikata S, Noguchi Y, Ukai T, Higuchi R, Wada K, Honda G, Supe AN, Yoshida M, Mayumi T, Gouma DJ, Deziel DJ, Liau KH, Chen MF, Shibao K, Liu KH, Su CH, Chan ACW, Yoon DS, Choi IS, Jonas E, Chen XP, Fan ST, Ker CG, Gimenez ME, Kitano S, Inomata M, Hirata K, Inui K, Sumiyama Y, Yamamoto M. Tokyo Guidelines 2018: flowchart for the management of acute cholecystitis. J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):55-72. doi: 10.1002/jhbp.516. Epub 2017 Dec 20.
PubMed 29045062Molavi I, Schellenberg A, Christian F. Clinical and operative outcomes of patients with acute cholecystitis who are treated initially with image-guided cholecystostomy. Can J Surg. 2018 Jun;61(3):195-199. doi: 10.1503/cjs.003517.
PubMed 29806817Bao J, Wang J, Shang H, Hao C, Liu J, Zhang D, Han S, Li Z. The choice of operation timing of laparoscopic cholecystectomy (LC) after percutaneous transhepatic gallbladder drainage (PTGBD) for acute cholecystitis: a retrospective clinical analysis. Ann Palliat Med. 2021 Aug;10(8):9096-9104. doi: 10.21037/apm-21-1906.
PubMed 34488395Lyu Y, Li T, Wang B, Cheng Y. Early laparoscopic cholecystectomy after percutaneous transhepatic gallbladder drainage for acute cholecystitis. Sci Rep. 2021 Jan 28;11(1):2516. doi: 10.1038/s41598-021-82089-4.
PubMed 33510242
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Delayed Cholecystectomy After Percutaneous Drainage in Moderate and Severe Cholecystitis (ESCAPE Trial)
- ClinicalTrials.gov ID
- NCT07161960
- Acronym / sponsor ID
- ESCAPE / SUR-2568-0197
- Keywords
- Acute cholecystitis, Percutaneous cholecystostomy, Laparoscopic cholecystectomy, Early LC, Delay LC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Yada SuwanUniversity, hospital or other
- Collaborators
- Chiang Mai University, Lampang Hospital, Phrae Hospital, Maharaj Nakorn Chiang Mai Hospital
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Laparoscopic Cholecystectomy | Experimental | Procedure: Laparoscopic cholecystectomyThe patients will undergo laparoscopic cholecystectomy (LC) within the same admission of PCC and after PCC for 72 hours, usually not more than 2 weeks. |
| Delay Laparoscopic Cholecystectomy | Experimental | Procedure: Laparoscopic cholecystectomyThe patients will undergo laparoscopic cholecystectomy (LC) after 6 weeks from PCC insertion, avoiding active inflammation and swelling |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic cholecystectomyLaparoscopic 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. | Procedure or surgery | Delay Laparoscopic Cholecystectomy, Early Laparoscopic Cholecystectomy |
Primary outcome
Comprehensive Complication Index from PCC and LC
Time frame: 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).
5 secondary outcomes
Nasaar Difficulty Scoring
Time frame: During the operation
Length of Hospital Stay (LOS)
Time frame: During enrollment to 3 months postoperative or date that complication resolves
Rate of Conversion to Open Cholecystectomy
Time frame: During the operation
Rate of Subtotal Cholecystectomy
Time frame: During the operation
Incidence of Bile Duct Injury
Time frame: During the operation to 3 months postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Results publication: PubMed 35610148Yamazaki S, Shimizu A, Kubota K, Notake T, Yoshizawa T, Masuo H, Sakai H, Hosoda K, Hayashi H, Yasukawa K, Umemura K, Kamachi A, Goto T, Tomida H, Seki H, Shimura M, Soejima Y. Urgent versus elective laparoscopic cholecystectomy following percutaneous transhepatic gallbladder drainage for high-risk grade II acute cholecystitis. Asian J Surg. 2023 Jan;46(1):431-437. doi: 10.1016/j.asjsur.2022.05.046. Epub 2022 May 21.
- Results publication: PubMed 33098966Woodward SG, Rios-Diaz AJ, Zheng R, McPartland C, Tholey R, Tatarian T, Palazzo F. Finding the Most Favorable Timing for Cholecystectomy after Percutaneous Cholecystostomy Tube Placement: An Analysis of Institutional and National Data. J Am Coll Surg. 2021 Jan;232(1):55-64. doi: 10.1016/j.jamcollsurg.2020.10.010. Epub 2020 Oct 21.
- Results publication: PubMed 29045062Okamoto K, Suzuki K, Takada T, Strasberg SM, Asbun HJ, Endo I, Iwashita Y, Hibi T, Pitt HA, Umezawa A, Asai K, Han HS, Hwang TL, Mori Y, Yoon YS, Huang WS, Belli G, Dervenis C, Yokoe M, Kiriyama S, Itoi T, Jagannath P, Garden OJ, Miura F, Nakamura M, Horiguchi A, Wakabayashi G, Cherqui D, de Santibanes E, Shikata S, Noguchi Y, Ukai T, Higuchi R, Wada K, Honda G, Supe AN, Yoshida M, Mayumi T, Gouma DJ, Deziel DJ, Liau KH, Chen MF, Shibao K, Liu KH, Su CH, Chan ACW, Yoon DS, Choi IS, Jonas E, Chen XP, Fan ST, Ker CG, Gimenez ME, Kitano S, Inomata M, Hirata K, Inui K, Sumiyama Y, Yamamoto M. Tokyo Guidelines 2018: flowchart for the management of acute cholecystitis. J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):55-72. doi: 10.1002/jhbp.516. Epub 2017 Dec 20.
- Results publication: PubMed 29806817Molavi I, Schellenberg A, Christian F. Clinical and operative outcomes of patients with acute cholecystitis who are treated initially with image-guided cholecystostomy. Can J Surg. 2018 Jun;61(3):195-199. doi: 10.1503/cjs.003517.
- Results publication: PubMed 34488395Bao J, Wang J, Shang H, Hao C, Liu J, Zhang D, Han S, Li Z. The choice of operation timing of laparoscopic cholecystectomy (LC) after percutaneous transhepatic gallbladder drainage (PTGBD) for acute cholecystitis: a retrospective clinical analysis. Ann Palliat Med. 2021 Aug;10(8):9096-9104. doi: 10.21037/apm-21-1906.
- Results publication: PubMed 33510242Lyu Y, Li T, Wang B, Cheng Y. Early laparoscopic cholecystectomy after percutaneous transhepatic gallbladder drainage for acute cholecystitis. Sci Rep. 2021 Jan 28;11(1):2516. doi: 10.1038/s41598-021-82089-4.
- Individual participant dataSharing planned: No. According to the ethic consideration by the committee of Research, Chiang Mai University, the identification and all treatment history will be reached by the researchers, data collectors and analyzers only to keep privacy for the participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic cholecystectomy in people with Acute Cholecystitis and Percutaneous Cholecystostomy, run by Yada Suwan at 1 site in Thailand.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 25 Sep 2025. 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 Thailand. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yada Suwan, Doctor of Medicine (+66 084-6561191, yada.suwan@cmu.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehensive Complication Index from PCC and LC (time frame: From enrollment to 3 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07161960, which also lists 6 linked publications.
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 Sep 2025.