INTERNATIONAL DELPHI CONSENSUS ON THE MANAGEMENT OF PERCUTANEOUS

CHOLEYSTOSTOMY IN ACUTE CHOLECYSTITIS (E-AHPBA, ANS, WSES Societies)

José M. Ramia1,2,3,, Mario Serradilla-Martín4,5,6, Celia Villodre1,2,3, Juan J. Rubio1,

Fernando Rotellar7, Ajith K. Siriwardena8*, Go Wakabayashi9*, Fausto Catena10* and
PERCHODEL Collaborative Study Group

*Should be considered senior authors

AFFILIATIONS

1. Department of Surgery, Hospital General Universitario Dr. Balmis, Alicante

(Spain)
2. ISABIAL, Alicante (Spain)
3. University Miguel Hernandez, Alicante (Spain)
4. Department of Surgery, Hospital Universitario Virgen de las Nieves, Granada
(Spain)
5. Instituto de Investigación Biosanitaria ibs.GRANADA, Granada (Spain)
6. Department of Surgery, School of Medicine, University of Granada, Granada
(Spain)
7. Department of Surgery, Clínica Universidad de Navarra, Pamplona (Spain)
8. Regional Hepato-Pancreato-Biliary Unit, Manchester Royal Infirmary,
Manchester (United Kingdom)
9. Department of Surgery, Ageo Central General Hospital, Ageo (Japan)
10. Emergency and Trauma Surgery, Bufalini Hospital, Cesena (Italy)

PERCHODEL Collaborative Study Group

Tomoyuki Abe (Higashihiroshima Medical Center, Japan), Yuta Abe (Keio University
School of Medicine, Japan), Fikri Abu-Zidan (The Research Office, College of Medicine
and Health Sciences, United Arab Emirates University, United Arab Emirates), Cándido

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F. Alcázar López (Hospital General Universitario Dr. Balmis, Spain), Ryusuke Amemiya
(Kawasaki Municipal Hospital, Japan), Bodil Andersson (Skåne University Hospital,
Sweden), Luca Ansaloni (IRCCS San Matteo Hospital, Italy), Anita Balakrishnan
(Cambridge University Hospitals NHS Foundation Trust, United Kingdom), Zsolt J.
Balogh (John Hunter Hospital, University of Newcastle, United Kingdom), Silvia
Carbonell (Hospital General Universitario Dr. Balmis, Spain), Ahmet Coker (Medicana
International Izmir Hospital, Turkey), Dimitrios Damaskos (Royal Infirmary of
Edinburgh, United Kingdom), Belinda De Simone (Infermi Hospital, Italy), Jonh Devar
(University of Witwatersrand , Chris Hani Baragwanath Academic Hospital, South
Africa), Isabella Frigerio (Pederzoli Hospital, Italy), Yusuke Fujita (Saitama City Hospital,
Japan), Sigheo Hayatsu (NHO Saitama Hospital, Japan), Shutaro Hori (School of
medicine, Keio University, Japan), Sho Ibuki (Shonantobu General Hospital, Japan),
Noriaki Kameyama (Ogikubo Hospital, Japan), Youichi Kawano (Nippon Medical School,
Japan), Andrew Kirkpatrick (Foothills Medical Centre, Canada), Jorg Kleeff (Martin
Luther University Halle, Germany), Yoram Kluger (Rambam Medical Center, Israel),
Rifat Latifi (Tucson Medical Center, USA), Santiago López Ben (Hospital Universitario
Dr. Josep Trueta, Spain), Giuseppe Malleo (University of Verona Hospital Trust, Italy),
Yuki Masuda (Federation of National Public Service Personnel Mutual Aid Associations
Tachikawa Hospital, Japan), Takuya Minagawa (International University of Health and
Welfare, Japan), Kohei Mishima (Research Institute Against Digestive Cancer - IRCAD -,
France), Ryohei Miyata (Saiseikai Kazo Hospital, Japan), Ernest Moore (Ernest E Moore
Shock Trauma Center at Denver Health, USA), Ryo Nishiyama (Saiseikai Yokohamashi
Tobu Hospital, Japan), Yusuke Ome (Tokyo Women's Medical University, Japan),
Junichi Saito (Inagi Municipal Hospital, Japan), Alejandro Serrablo (Hospital
Universitario Miguel Servet, Spain), Masaya Shito (Kawasaki Municipal Kawasaki
Hospital, Japan), Kjetil Soreide (Stavanger University Hospital, Norway), Oliver Strobel
(Medical University of Vienna, Austria), Michael Sugrue (Letterkenny University
Hospital, Ireland), Keiichi Suzuki (NHO Tochigi Medical Center, Japan), Yutaka Takigawa
(Tokyo Dental College Ichikawa General Hospital, Japan), Moriaki Tomikawa (Tochigi
Cancer Center, Japan), Hidejiro Urakami (NHO Tokyo Medical Center, Japan), Carlo
Vallicelli (Maurizio Bufalini Hospital, Italy), Taiga Wakawayashi (Ageo Central General
Hospital, Japan), Dieter Weber (Royal Perth Hospital, Australia)

2
Corresponding author:
Pending

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INTRODUCTION

Acute cholecystitis (AC) accounts for 30% of emergency admissions to general

surgery departments and is the second most frequent cause of complicated intra-
abdominal infection [1]. Currently, laparoscopic cholecystectomy (LC) is the gold
standard in the treatment of AC. However, in patients with high surgical risk,
comorbidities, or advanced age, LC is associated with high rates of morbidity (31%),
and postoperative mortality (4%); much higher than those obtained in patients with
low surgical risk [2].
In patients with a level of surgical risk that outweighs the possible benefits of
surgery, non-surgical treatments have become widespread [3,4]. The most frequently
used alternative to surgery is percutaneous cholecystostomy (PC), which consists of
the percutaneous puncture of the gallbladder and the placement of a drainage
catheter [5]
The increase in the use of PC over the last decades is due to two main factors
[6]: population aging, which increases the number of patients with high surgical risk,
and the publication of the Tokyo Guidelines (TG) and the World Society of Emergency
Surgery (WSES) Guidelines devised to standardize the diagnosis, management, and
treatment of AC, and which recommend the use of PC in selected groups of patients
[3,4,7,8]. Recently, however, the utility of PC versus LC in patients with high surgical
risk has been questioned, and it has been suggested that PC may be over-used [4,9].
The theoretical advantages offered by PC are the rapid resolution of sepsis and
the optimal preparation of the patient for elective LC [5,9]. Its main drawback is the
possibility of recurrence of AC or other biliary events while awaiting LC. Many
questions, indications, and management of PCs are unsolved.
The Delphi method is a well-established approach for answering a research
question by identifying a consensus view among subject experts. It allows for reflection
among participants, who can reconsider their opinions based on the anonymized
opinions of their peers [10-13]. First, available evidence should be reviewed to develop
the Delphi consensus questionnaire. Finally, a Delphi process is delivered to formulate
these guidance and recommendations (11-14).

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 This study defines an international consensus on indications and PC
management using Delphi methodology with contributions from experts from three
surgical societies.

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METHODS

This Delphi consensus consisted of four phases, each informing the subsequent
phase. The study did not require approval by an Ethics committee because there was
no contact with patients and all expert participation was on a voluntary basis.

Phase 1: Evidence acquisition

A non-systematic review was undertaken (JR and JJR) to acquire the most new
and relevant information on the use of PCs in AC. using the keywords
“cholecystostomy” and “acute cholecystitis”” (years 2018-2023) in Pubmed database.

Phase 2: Expert panel virtual discussion

A core expert committee of six experts (JR, FC, FR, MSM, AKS, GW) on AC was
invited and agreed to participate. The members represented three societies (EAHPBA
[European-African Hepato-Pancreato-Biliary Association, the Japanese Group led by
GW, and WSES [World Society of Emergency Surgery]). This panel of experts discussed
the themes identified in Phase 1 over structured virtual discussion sessions. Finally, the
Core group included 27 questions in the Delphi and asked experts (Table 1).

Phase 3: Delphi process

Following phase 2, Delphi methodology was used to quantify consensus in the
participating Group. Delphi was performed electronically using (Google Forms®,
Mountain View, CA, USA). The language used to carry out the questionnaire was
English. The Delphi was distributed to all phase 2 Core group members and 60 key
opinion leaders in AC worldwide with sound theoretical knowledge of the area and a
high degree of practical expertise acknowledged by their peers in the field.
Each expert received a link to an online questionnaire via email. All participants
were asked to propose additional criteria or reflections they considered necessary in
free text fields only in the first round. All responses were treated anonymously. Only
the initials of each participant were recorded, along with their hospital and country of
origin, to avoid duplication of questionnaires. A round electronic consensus exercise
was then conducted (10-14) (Round 1: 11/January/2024 to 11/February/2024; Round

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2: 1/April/2024 to 15/May/2024). A first email was sent to the experts at the beginning
of each round, followed by two weekly reminders. An interval of three weeks between
rounds was scheduled to analyze the results and prepare for the next round.
Participants were asked to indicate their 'agreement/disagreement' with the
proposed parameters using the questionnaire comprising questions to be answered on
a 5-point Likert scale: 1: "totally disagree," 2: "disagree," 3: "neither agree nor
disagree, "4: "agree," and 5: "totally agree" (13). Survey items with less than 70%
consensus were removed from the second survey round, with the consensus threshold
achieved disseminated to all participants. For inclusion in the final recommendations,
each survey item had to have reached a group consensus (≥ 70% agreement) by the
end of the two survey rounds. Items that did not achieve consensus were also
discussed in phase 4.
To define the degree of agreement, the following criteria were used:
- "Unanimity": when 100% of the participants gave the same response on the Likert
scale.
- "Agreement": when ≥ 80% of the participants agreed.
- "Majority": when ≥ 70% agreed.
- "Discrepancy": when < 70% agreed.

Phase 4: Generation of recommendations

The Core group summarized and reported the recommendations within this
manuscript based on the consensus results of the Delphi process.

Statistical analysis
Only complete questionnaires were considered, and each round's response rate
was recorded. The results for each round were expressed as the percentage of
responders for each answer option (from 1 to 5), together with the median and range
for each item. The analysis assessed the responses in the online platform's database.
Descriptive statistics for categorical variables were reported as numbers and
percentages, while continuous variables were reported as means and standard
deviations (SD). The delta of changes between rounds 1 and 2 was calculated. The p

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value was calculated using the chi-square test with Yates correction for percentages of
responses (4+5), and U Mann- Whitney-Wilcoxon Test for medians of each category.
RESULTS

The survey was sent to 66 surgeons (20 by Society) plus the Core group. There
were 58 responders in the first round, and 54 completed both rounds (82% of
invitees) and these were the answers included in the analysis. Surgeons were from:
Japan (22), Spain (7), Italy (7), United Kingdom (3), Australia, France, and USA (2),
Austria, Germany, Ireland, Israel, Norway, South Africa, Sweden, Turkey, and the
United Arab Emirates (1). The median age was 50 years (IQR: 43-56). Thirty-two
surgeons work in a public academic hospital, seven in a public non-academic, thirteen
in a private academic hospital, and two in a private non-academic center. The median
of beds in the hospital was 675 (IQR: 400-970). The hospital has a 24-hour PC available
in 48/54 (88.8%), an ERCP 24-hour in 40/54 (74.1%), EUS 24-hour in 19/54 (35.2%), and
a surgeon on call in all centers.
In the first round, only seven questions reached 70%, adding agree and totally
agree on answers (table 1) and passing to 2nd round. The questions were: Question 1:
In patients with acute cholecystitis, when there is a clear indication of PC it is not
necessary to wait 48 hours to be carried out (91.4%); Question 2: Surgery is the first
therapeutic option for the TG grade II acute cholecystitis in a patient suitable for
surgery (91.4%); Question 3: Before PC removal a cholangiography should be done
(79.3%); Question 4: There is no indication for PC in Tokyo Guidelines (TG) grade I
patients (72.4%); Question 5: Transhepatic approach is the route of choice for PC
(72.4%); Question 6: If there is a normal cholangiogram, PC will be closed and retired
in 48 hours if there is no clinical/analytical worsening (70,7%); Question 7: After PC,
laparoscopic cholecystectomy is the preferred approach (93.1%).
In the second round, six of seven questions reached > 70%. The question, “If
there is a normal cholangiogram, PC will be closed and retired in 48 hours if there is
not a clinical/analytical worsening,” received only 67.27% of agree plus totally agree,
so it was not included in the final recommendations (Tables 2 and 3). The Delta
between both rounds was calculated (Table 4).

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DISCUSSION
In our Delphi study, there was only a consensus on six of twenty-seven
questions covering all aspects of PC management in AC. Three of them, on the
indication: no need to wait 48 hours if the indication is evident from the first moment,
and PC should not be performed in AC grades I and II of TG. The other three focused on
technique: the best route for performing PC is transhepatic, and before removing the
PC a cholangiography must be performed, and late management: laparoscopic
cholecystectomy is the treatment of choice, even if PC has been performed.
PC was first applied by Radder in 1980 (14). PC is a procedure with a high
technical success rate and high disposable (88% of our responders had PC 24/7). It is
safe and associated with low morbidity, a systematic review reported a complication
rate of 14%, and allows rapid control of the focus of infection and rehabilitation of the
patients for scheduled surgery (14-17). But PC has some limitations: patient
discomfort, around 25% of patients treated with PC required the placement of a new
PC, readmission rates are high (30%), and PC could solve the initial clinical scenario,
but biliary lithiasis, the source of the problem, is not solved (18).
Now, we will compare previous publications on the questions included and
approved in Delphi.
 Performing PC as soon as decision is taken without waiting 48 hours of clinical
evaluation. Some manuscripts confirm that early PC reduces hospital stay and
slows the progression of the inflammatory condition (19). WSES guidelines
recommended to wait 24-48 h in patients not suitable for surgery and treating with
antibiotics and close observation (4). In TG guidelines an early/urgent PC is
recommended but no precise data about timing is included (8). So, this could be
the first clinical outstanding recommendation of this Delphi, the PC should be
done, if it is indicated, as soon as possible.
 PC in different grades of AC and specific clinical scenarios: There is a clear
consensus that patients with AC TG Grade I and II should be operated on (4,8,20).
For Grade III patients, PC should not be considered the first option if the surgeon
finds that patient is fit for surgery (4,8). The CHOCOLATE randomized trial

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 comparing high surgical risk patients treated with PC or LC did not find differences
in mortality rates but observed higher rates of complications, reoperations, and
recurrence of biliary pathology in PC patients [21]. So, the main accepted indication
of PC is patients with AC who are unable to undergo surgery due to comorbidities
(unfit for surgery and/or shock or severe sepsis) [4,8,19]. Some manuscripts and
guidelines also admit other indications for PC, such as AC > 72 hours, marked local
inflammation, or leukocyte count > 18000 L/mm3 (3,4,14). We asked in our Delphi
about these extra indications for PC, and the recommendation was not to use PC
based on fragility (ASA III and IV), suspected common bile duct stones, or difficult
cholecystectomy. So, the Delphi answers have a great adherence to WSES and TG
guidelines and considered PC the best options in unfit or extremely sick patients,
not considering PC a good option for extra scenarios.
 Clinical management of PC: There has yet to be an international consensus about
the management of PC (4,8). One of the most controversial issues is the duration of
the drain placement. Some authors recommend keeping it in place until surgery or
at least six weeks since early removal is associated with complications. Others
suggest its withdrawal when the AC has resolved (21). Our answers show that 69%
of the responders disagree or totally disagree with a policy of 6 weeks open. In the
first round, the question about if cholangiogram is normal, PC will be closed and
retired in 48 hours if there is not a clinical/analytical worsening pass the cutoff of
70% in first round but not in the second round. There is a clear consensus that best
route for performing PC is transhepatic, and before removing the PC a
cholangiography must be performed. Management of PC is not usually included in
guidelines but would be very interesting for avoiding variability (4,8). But we could
not recommend a clear timing of PC (22).
 Cholecystectomy after PC: In the literature, the rate of cholecystectomy after PC
varies from 36% to 57% (14,23-30). There are no reports providing quality scientific
evidence on the best timing for surgery after PC. TG and WSES did not perform
clear indications about this topic (4,8,23-30). The literature data are (14,23-30):
total healthcare costs are lower in patients who undergo cholecystectomy in the
first two months after PC; a study comparing early cholecystectomy (0-8 weeks)
versus late cholecystectomy (> 8 weeks) found that the early cholecystectomy

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 group had a higher risk of complications and longer hospital stay; a 2021
systematic review concluded that the interval of 9-10 weeks after PC is the optimal
time for cholecystectomy and finally a 2022 meta-analysis comparing
cholecystectomy during the first 30 days and at a later did not find differences in
the clinical results (23-30). Other point that has not been demonstrated is that
cholecystectomy is difficult after PC, so some surgeons recommend open surgery
after PC. In our Delphi, there was a clear consensus about laparoscopic approach
should be performed.

Although this is not the objective of this manuscript, there is another

therapeutical option for patients with clear PC indication. Endoscopic Ultrasound-
Guided Gallbladder Drainage (EUS-GBD) has also been proven to be a feasible
technique for treating AC unfit for surgery with fewer adverse events and a lower
reintervention rate than PC (31,32). The advantages of EUS-GBD vs PC include
internalization of bile, obviating the risk of recurrent cholecystitis following PC removal
and the risk of bleeding, and being associated with less post-procedural pain (31,32).
However, the 24-hour availability of EUS is less than that of PC; for example, the
difference is evident in the centers where our panel members work (88 vs. 35%), and
the need for advanced endoscopic expertise not disposable in all centers should be
considered.
The limitations of this study are intrinsic to any Delphi Study, and the strength
is that panelists are from all over the world, which decreased the bias of being from
only one country with a specific health system.
In conclusion, only six statements about PC management after AC got an
international consensus. Clear guidelines about the management of PC are necessary.

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