Effectiveness of direct needle puncture for complete hepaticojejunostomy anastomotic stricture after pancreaticoduodenectomy (with video).

A 79-year-old Japanese woman, who had undergone pancreaticoduodenectomy 6 months prior to presentation owing to pancreatic cancer, complained of jaundice with high fever. Computed tomography revealed proximal bile duct dilatation with complete hepaticojejunostomy anastomotic stricture (HJAS). We performed a single-balloon endoscopy for biliary drainage. The presence of a scar-like feature surrounding the anastomosis was identified as the HJAS. White-light imaging during single-balloon endoscopy revealed that the HJAS contained a milky whitish area (MWA), suggesting that a membranous and fibrosis layer affected continuous inflammation around the center of the anastomosis (within a scar-like feature). Endoscopic dilatation was performed using an endoscopic injection needle, with the MWA used as an indicator. A 23-gauge endoscopic injection needle was used to penetrate the center of the blind lumen within the MWA, and a pinhole was created in the stricture. After confirming the position of the proximal bile duct using a contrast medium with the needle, an endoscopic guidewire with a cannula was inserted into the pinhole. A through-the-scope sequential balloon dilator was used to dilate the stricture, and a plastic stent was inserted into the proximal bile duct. This endoscopic intervention led to positive outcomes. In cases of complete HJAS occlusion, an endoscopic approach to the bile duct is difficult because the anastomotic opening of the HJAS is not visible. Thus, puncturing within the MWA, which can be used as a scar-like landmark within a complete membranous HJAS, is considered a useful endoscopic strategy.

Outcomes of multi-hole self-expandable metal stents versus fully covered self-expandable metal stents for malignant distal biliary obstruction in unresectable pancreatic cancer.

Objectives: The multi-hole self-expandable metal stent (MHSEMS) is a novel SEMS with multiple small side holes on the covering membrane to prevent stent migration while minimizing tumor ingrowth. This study aimed to evaluate the clinical outcomes of MHSEMS in comparison with conventional covered SEMS (c-CMS). Methods: Consecutive patients with unresectable pancreatic cancer who underwent initial SEMS placement (MHSEMS or c-CMS) for malignant distal biliary obstruction were analyzed. Technical success, clinical success, causes of recurrent biliary obstruction (RBO), non-RBO adverse events, time to RBO (TRBO), and endoscopic reintervention were compared between groups. Results: A total of 65 patients were included (MHSEMS: 27, c-CMS: 38). The technical success, clinical success, and non-RBO adverse event rates were similar between groups. Although stent migration was less frequently observed in the MHSEMS group (0% vs. 17.6%, p = 0.032), overall RBO rates were similar between groups (53.8% vs. 55.9%, p > 0.99). The most common cause of RBO within 14 days in the MHSEMS group was non-occlusion cholangitis. Median TRBO was significantly shorter in the MHSEMS group (101 vs. 227 days, p = 0.030) and MHSEMS was an independent predictor for shorter TRBO in multivariate analysis (hazard ratio, 2.27; 95% confidence interval, 1.06-4.86; p = 0.034). Outcomes after endoscopic interventio were not significantly different between groups. Stent removal was successful in all attempted cases in both groups. Conclusions: MHSEMS was associated with a significantly shorter TRBO compared to c-CMS. Further modifications of the present MHSEMS may be needed.

Intrabiliary pressure in the pathophysiology of extra hepatic biliary obstruction.

Background and Aim: The aim of this study was to evaluate the role of intrabiliary pressure (IBP) in the pathophysiology of extrahepatic biliary obstruction (EHBO) during percutaneous transhepatic biliary drainage (PTBD). Materials and Methods: Adult patients with EHBO who underwent PTBD were prospectively enrolled. IBP was recorded during primary PTBD. The parameters of interest were age, gender, etiology of EHBO, baseline and post-PTBD liver function tests, duration for resolution of jaundice (decrease in total serum bilirubin ≥30% of baseline or <2 mg/dL), cholangitis, bile cultures, and serum albumin levels. The level of EHBO was divided into three types: Type 1 - secondary biliary confluence involved; Type 2 - primary biliary confluence involved; Type 3 - mid and distal common bile duct obstruction. Results: IBP was measured in 102 patients, and finally, 87 patients, including 52 (59.77%) females, were analyzed. The mean age of the patients was 56.1±11.6 years. The most common etiology of EHBO was carcinoma of the gallbladder in 44 (50.6%) patients. The mean IBP was 18.41±3.91 mmHg. IBP was significantly higher in Type 3 EHBO compared to Type 1 and 2 (p=0.012). A significant correlation was seen between IBP and baseline total serum bilirubin (p<0.01). There was a negative correlation between IBP and baseline serum albumin (p=0.017). In 56.3% of patients, resolution of jaundice was observed by day 3, but this was not significantly associated with IBP (p=0.19). There was no correlation between IBP and cholangitis (p=0.97) or bacterial cultures (p=0.21). Conclusion: IBP was significantly associated with the type of EHBO, baseline serum bilirubin, and albumin levels. IBP could not predict cholangitis or the resolution of jaundice after PTBD.

Same versus separate sessions of endoscopic ultrasound-guided fine-needle biopsy and endoscopic retrograde cholangiopancreatography for distal malignant biliary obstruction: a propensity score-matched study.

BACKGROUND: Same-session endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP) is an attractive policy for patients with distal malignant biliary obstruction (DMBO) requiring fine-needle biopsy (FNB) and biliary drainage. However, scanty and conflicting data exists regarding safety and efficacy when comparing these two procedures performed in same versus separate sessions. METHODS: Single-center, retrospective, propensity score-matched study including patients with DMBO who underwent EUS-FNB followed by ERCP during the same or separate sessions. The primary outcome was the safety of the procedure [number of patients experiencing adverse events (AEs), overall AEs, its severity, post-ERCP pancreatitis (PEP)]. Secondary outcomes were successful ERCP, use of advanced cannulation techniques, EUS-FNB adequacy, length of hospital stay, overall procedure time, and time to recurrent biliary obstruction. RESULTS: After propensity matching, 87 patients were allocated to each group. AEs developed in 23 (26.4%) vs. 17 (19.5%) patients in the same and separate sessions group, respectively (p = 0.280). The overall number, the severity of AEs, and the rate of PEP were similar in the two groups. Secondary outcome parameters were also comparable in the 2 groups. CONCLUSIONS: Same-session EUS-FNB followed by ERCP with biliary drainage is safe and does not impair technical outcomes of tissue adequacy and biliary cannulation.

Efficacy and safety of EUS-guided hepatogastrostomy: A systematic review and meta-analysis.

EUS-guided hepaticogastrostomy (EUS-HGS) is one of the preferred methods in biliary drainage where ERCP fails or is contraindicated. The clinical outcomes of EUS-HGS are not well studied because of variability in procedure technique. We conducted a search of multiple electronic databases and conference proceedings from inception through January 2023. The clinical outcomes studied were pooled technical success, clinical success, and adverse events. Standard meta-analysis methods were used using the random-effects model, and heterogeneity was studied by I 2 statistics. We analyzed 44 studies, which included 19 prospective and 25 retrospective studies. The pooled technical success rate of EUS-HGS was 94.4% (confidence interval [CI], 92.4%-95.9%; I 2 = 0%), and the pooled clinical success rate was 88.6% (CI, 83.7%-92.2%; I 2 = 0%). The pooled adverse outcomes with EUS-HGS were 23.8% (CI, 19.6%-28.5%; I 2 = 0%). The mild adverse event rate associated with HGS was 5.8% (4.2%-8.1%; I 2 = 0%), moderate adverse event rate was 12.1% (9.1%-15.8%; I 2 = 16%), and severe adverse event rate was 4.2% (3.0%-5.7%; I 2 = 61%), whereas fatal adverse event rate was 3.2% (1.9%-5.4%; I 2 = 62%). On subgroup analysis, the pooled rate of adverse events of EUS-guided hepaticogastrostomy with antegrade stenting was 13.3% (95% CI, 8.2%-21.0%). The pooled technical success with EUS-guided hepaticogastrostomy with antegrade stenting was 89.7% (95% CI, 82.6%-94.2%), and clinical success was 92.5% (95% CI, 77.9%-97.7%). On the basis of our analysis of EUS-HGS, the overall technical success was 94.4%, and the clinical success rate was 88.6%, and the overall adverse events were reported to be 23.8%. These data can also help improve the clinical benefits of EUS-HGS in the selected patients in whom it is performed.

Endoscopic biliary drainage for distal bile duct obstruction due to pancreatic cancer.

Approximately 60% of pancreatic cancers occur in the pancreatic head and may present as obstructive jaundice due to bile duct invasion. Obstructive jaundice often leads to poor general conditions and acute cholangitis, interfering with surgery and chemotherapy and requiring biliary drainage. The first choice of treatment for biliary drainage is the endoscopic transpapillary approach. In unresectable tumors, self-expandable metal stents (SEMSs) are most commonly used and are classified into uncovered and covered SEMSs. Recently, antireflux metal stents and large- or small-diameter SEMSs have become commercially available, and their usefulness has been reported. Plastic stents are infrequently used in patients with resectable biliary obstruction; however, owing to the recent trend in preoperative chemotherapy, SEMSs are frequently used because of the long time to recurrent biliary obstruction. Endoscopic ultrasound-guided biliary drainage (EUS-BD) is often performed in patients who are not eligible for the transpapillary approach, and favorable outcomes have been reported. Different EUS-BD techniques and specialized stents have been developed and can be safely used in high-volume centers. The indications for EUS-BD are expected to further expand in the future.

Need for a targeted perioperative antibiotic treatment protocol for patients with preoperative biliary drainage undergoing pancreaticoduodenectomy.

PURPOSE: To evaluate the bacterobilia in patients undergoing pancreaticoduodenectomy (PD) based on whether they carry a preoperative biliary drainage or not and to analyse if a targeted perioperative antibiotic treatment based on the expected microbiology leads in no differences in Surgical Site Infections (SSI) between the groups. METHODS: Retrospective observational single-center study of patients undergoing pancreaticoduodenectomy with preoperative biliary stent (group P, Prosthesis) and without stent (group NP, No Prosthesis). Postoperative complications including SSI and its subtypes were analyzed after applying a targeted perioperative antibiotic treatment protocol with cefotaxime and metronidazole (group NP) and piperacillin-tazobactam (group P). RESULTS: Between January 2014 and December 2021, 127 patients were treated (84 in group NP and 43 in group P). Intraoperative cultures were positive in 16.7% (group NP) vs 76.7% (group P, p < 0.01). Microorganisms isolated in group NP included Enterobacterales (10.7%) and Enterococcus spp. (7.1%) with no Candida detected. In group P: Enterobacterales (51.2%), Enterococcus spp. (48.8%), and Candida (16.3%) were higher (p < 0.01%). No differences in morbidity and mortality were observed between the groups. SSI rate was 17.8% in group NP and 23.2% in group P (ns). CONCLUSION: Bacterobilia differs in patients with biliary drainage, showing a higher presence of Enterobacterales, Enterococcus spp., and Candida. There were no differences in SSI incidence after applying perioperative antibiotic treatment tailored to the expected microorganisms in each group. This raises the need to reconsider conventional surgical prophylaxis in patients with biliary stent.

Role of endoscopic ultrasound-guided biliary drainage for palliation of malignant biliary obstruction.

Endoscopic ultrasound-guided biliary drainage (EUS-BD) directs bile flow into the digestive tract and has been mostly used in patients with malignant biliary obstruction (MBO) where endoscopic retrograde cholangiopancreatography-guided biliary drainage was unsuccessful or was not feasible. Lumen apposing metal stents (LAMS) are deployed during EUS-BD, with the newer electrocautery-enhanced LAMS reducing procedure time and complication rates due to the inbuilt cautery at the catheter tip. EUS-BD with electrocautery-enhanced LAMS has high technical and clinical success rates for palliation of MBO, with bleeding, cholangitis, and stent occlusion being the most common adverse events. Recent studies have even suggested comparable efficacy between EUS-BD and endoscopic retrograde cholangiopancreatography as the primary approach for distal MBO. In this editorial, we commented on the article by Peng et al published in the recent issue of the World Journal of Gastrointestinal Surgery in 2024.

Comparative efficacy of endoscopic ultrasound-guided biliary drainage versus endoscopic retrograde cholangiopancreatography as first-line palliation in malignant distal biliary obstruction: a systematic review and meta-analysis.

Background: Malignant distal biliary obstruction (MDBO) is a challenging clinical condition commonly managed with endoscopic retrograde cholangiopancreatography (ERCP). However, endoscopic ultrasound-guided biliary drainage (EUS-BD) has emerged as an alternative, especially in complex cases where ERCP fails or is deemed risky. This study aimed to compare the efficacy, safety and cost-effectiveness of EUS-BD vs. ERCP in the palliation of MDBO. Methods: We conducted a systematic review and meta-analysis, following PRISMA guidelines. Three databases were searched up to December 2023, including MEDLINE/PubMed, OVID and the Cochrane Central Register of Controlled Trials, for studies comparing EUS-BD with ERCP. Primary outcomes were technical and clinical success rates, while secondary outcomes included procedural times, hospital stay duration, 30-day mortality, reintervention rates, and adverse events such as pancreatitis. Results: Seven studies involving 1245 patients met the inclusion criteria. The meta-analysis revealed that EUS-BD had a technical success rate of 92%, compared to 85% for ERCP. Clinical success rates were similar for both EUS-BD and ERCP, at approximately 89%. EUS-BD was associated with a significantly lower incidence of pancreatitis (2% vs. 10% for ERCP). Conclusions: EUS-BD offers a viable and potentially superior alternative to ERCP for the primary palliation of MDBO, particularly in terms of technical success and a lower risk of pancreatitis. These findings support the adoption of EUS-BD in clinical settings equipped to perform this technique, though future research should focus on long-term outcomes and further economic analysis to solidify these recommendations.

Management of biliary complications after LDLT.

Biliary complications (BC) in the recipient continue to be an as yet, unresolved issue following living donor liver transplantation (LDLT). Bile leaks (BL) and biliary anastomotic strictures (BAS) are the most common BCs, with the latter contributing to close to 80%. With increasing expertise, endoscopic treatment with endoscopic retrograde cholangiography (ERC) [the first-line treatment] and percutaneous transhepatic cholangiography (PTC) with percutaneous transhepatic biliary drainage (PTBD) alone or in combination with ERC lead to successful management in a majority of these cases. However, prediction of difficulty of endoscopic success in biliary strictures, optimal duration of indwelling stents and their planned removal, management options in high-grade strictures (HGS) and the long-term outcome of patients requiring intervention for BC's are still unanswered questions in this setting. This review will try to summarise pertinent issues, novel insights and finally propose basic principles to be adhered to when dealing with the gamut of possible biliary complications after LDLT.

Endoscopic ultrasound-guided biliary interventions.

Endoscopic ultrasound (EUS)-guided biliary drainage (EUS-BD) includes EUS-guided hepaticogastrostomy (EUS-HGS), EUS-guided choledochoduodenostomy (EUS-CDS), EUS-guided gallbladder drainage (EUS-GBD), EUS-guided antegrade stenting (EUS-AG) and EUS-guided rendezvous (EUS-RV). While EUS-HGS, EUS-CDS and EUS-GBD are transluminal drainage procedures, EUS-AG is a traspapillary drainage procedure and EUS-RV is a procedure intended to facilitate endoscopic retrograde cholangio pancreatography (ERCP) in instances of failed cannulation. These procedures were initially developed as options for endoscopic salvage of failed ERCP, but have evolved to become first-line interventions also for select indications over time as the technique and expertise improved. Several randomised controlled trials have demonstrated EUS-BD, especially EUS-CDS has similar or even better outcomes as compared to ERCP in malignant biliary obstruction. However, widespread adoption of these modalities is limited by the availability of expertise, steep learning curve, lack of standardization of techniques and cost. In this review, we aim to provide an overview of various EUS-BD procedures including the indications, accessories, technique, outcomes and follow-up of each of these procedures.

A case of an intraabdominal, but extrahepatic ruptured percutaneous transhepatic biliary drainage and its following rescue. A case report and literature review.

Percutaneous transhepatic biliary drainage is a well-established technique for the treatment of biliary obstruction in patients with failed endoscopic approaches. We report on an 82-year-old man with a history of cholangiocarcinoma treated with pancreaticoduodenectomy who presented with recurrent cholangitis and sepsis. Percutaneous transhepatic biliary drainage was performed after unsuccessful endoscopic retrograde cholangiography, which initially improved his condition. However, due to an accidental dislodgement, there was an intra-abdominal fracture of the drain which led to biliary peritonitis and clinical deterioration. The fractured intrahepatic drain was successfully extracted in our angio suite, and a novel subcutaneous fixation technique was introduced to prevent similar occurrences in the future. This case study signifies the role of interventional radiology in the management of percutaneous transhepatic biliary drainage complications and the importance of preventative measures to avoid dislodgement.

Endoscopic ultrasound-guided biliary drainage using electrocautery-enhanced lumen-apposing metal stent for malignant biliary obstruction: A promising procedure.

In this editorial, we comment on the article by Peng et al. Palliative drainage for biliary obstruction resulting from unresectable malignant lesions includes internal and external drainage. The procedures of biliary drainage are usually guided by fluoroscopy or transcutaneous ultrasound, endoscopic ultrasound (EUS), or both. Endoscopic retrograde cholangiopancreatography (ERCP) has been primarily recommended for the management of biliary obstruction, while EUS-guided biliary drainage and percutaneous transhepatic biliary drainage (PTBD) are alternative choices for cases where ERCP has failed or is impossible. PTBD is limited by shortcomings of a higher rate of adverse events, more reinterventions, and severe complications. EUS-guided biliary drainage has a lower rate of adverse events than PTBD. EUS-guided biliary drainage with electrocautery-enhanced lumen-apposing metal stent (ECE-LAMS) enables EUS-guided biliary-enteric anastomosis to be performed in a single step and does not require prior bile duct puncture or a guidewire. The present meta-analysis showed that ECE-LAMS has a high efficacy and safety in relieving biliary obstruction in general, although the results of LAMS depending on the site of biliary obstruction. This study has highlighted the latest advances with a larger sample-based comprehensive analysis.

Revolutionizing palliative care: Electrocautery-enhanced lumen-apposing metal stents in endoscopic-ultrasound-guided biliary drainage for malignant obstructions.

Patients with malignant biliary obstruction, following endoscopic retrograde cholangiopancreatography (ERCP) failure could be referred for endoscopic-ultrasound-guided biliary drainage through electrocautery-enhanced (ECE) lumen-apposing metal stent (LAMS) placement. However, the efficacy and safety of ECE-LAMS in this scenario have remained debatable due to minimal scientific evidence. The current confirmed 91.0% clinical success, 96.7% technical success, 7.3% reintervention rate, and 17.5% adverse events, following the treatment of malignant biliary obstruction with ECE-LAMS delivery. Finally, ECE-LAMS proved to be a generalizable strategy for managing biliary obstruction for patients who were excluded from ERCP.

Unveiling the potential of electrocautery-enhanced lumen-apposing metal stents in endoscopic ultrasound-guided biliary drainage.

This editorial delves into Peng et al's article, published in the World Journal of Gastrointestinal Surgery. Peng et al's meta-analysis investigates the effectiveness of electrocautery-enhanced lumen-apposing metal stents (ECE-LAMS) in ultrasound-guided biliary drainage for alleviating malignant biliary obstruction. Examining 14 studies encompassing 620 participants, the research underscores a robust technical success rate of 96.7%, highlighting the efficacy of ECE-LAMS, particularly in challenging cases which have failed endoscopic retrograde cholangio pancreatography. A clinical success rate of 91.0% underscores its impact on symptom alleviation, while a reasonably tolerable adverse event rate of 17.5% is observed. However, the 7.3% re-intervention rate stresses the need for post-procedural monitoring. Subgroup analyses validate consistent outcomes, bolstering the applicability of ECE-LAMS. These findings advocate for the adoption of ECE-LAMS as an appropriate approach for biliary palliation, urging further exploration in real-world clinical contexts. They offer valuable insights for optimizing interventions targeting malignant biliary obstruction management.

Endoscopic ultrasound-guided rendezvous techniques for difficult biliary cannulation: Technical review.

Endoscopic retrograde cholangiopancreatography (ERCP) is the standard procedure for the diagnosis and treatment of biliary diseases. However, selective biliary cannulation, the essential first step in ERCP, can sometimes fail due to anatomical variations or technical limitations. In these cases, the endoscopic ultrasound-guided rendezvous technique (EUS-RV) offers a valuable salvage option. Nevertheless, it is crucial to be aware of potential adverse events associated with bile duct puncture. To optimize the success rate and safety of EUS-RV, understanding the basic techniques, technical tips for each procedural step, and troubleshooting strategies for potential difficulties is essential. This review article summarizes the clinical outcomes and technical considerations of EUS-RV, including a comprehensive analysis of the current evidence.

Defining failure of endoluminal biliary drainage in the era of endoscopic ultrasound and lumen apposing metal stents.

The role of endoscopy in pathologies of the bile duct and gallbladder has seen notable advancements over the past two decades. With advancements in stent technology, such as the development of lumen-apposing metal stents, and adoption of endoscopic ultrasound and electrosurgical principles in therapeutic endoscopy, what was once considered endoscopic failure has transformed into failure of an approach that could be salvaged by a second- or third-line endoscopic strategy. Incorporation of these advancements in routine patient care will require formal training and multidisciplinary acceptance of established techniques and collaboration for advancement of experimental techniques to generate robust evidence that can be utilized to serve patients to the best of our ability.

Initial Experience of Pancreaticoduodenectomy in a Newly Developed Hepato-Pancreato-Biliary Unit Serving in a Lower-Middle-Income Country.

Introduction: Pancreaticoduodenectomy (PD) is the only potentially curative treatment for pancreatic head adenocarcinoma. This study aimed to determine the short-term outcomes of PD performed over 1 year at a newly established hepato-pancreatico-biliary unit in Khyber Pakhtunkhwa province of Pakistan. Material and Methods: A retrospective analysis of a prospectively maintained hospital information system (HIS) was undertaken of all patients referred to the unit between May 2021 and August 2022. Data were collected from the medical records of patients in the HIS. Data were analyzed for primary location, age, complications, and operative parameters. Results: The primary sites of disease were ampulla (n = 18, 52.9%), pancreas (n = 11, 32.4%), and duodenum (n = 5, 14.7%). The median duration of surgery was 7 h. 16 (47.1%) patients required blood transfusion either intraoperatively or in the perioperative period. Patients with pre-operative biliary drainage (PBD) were more likely to have multidrug-resistant positive bile cultures with a P-value of 0.2 (n = 12 [35.3%] vs. n = 5 [14.7%]). Overall morbidity was 38.2%. The most common complications were wound infection (n = 12, 35.3%), delayed gastric emptying (n = 6, 17.6%), and type B pancreatic fistula (n = 3, 8.8%). The complication rate was higher in patients with biliary stenting (n = 11 [32.4%] vs. n = 2 [5.9%]; P = 0.06). The median length of hospital stay for patients without complications was less (6 vs. 12 days; P < 0.001). The complication rate was lower in total laparoscopic PD (TLPD) with P = 0.4 (TLPD: 2.9%, open: 23.5%, laparoscopic assisted: 11.8%). 90-day mortality was zero. Conclusion: Short-term outcomes for PD in our facility are comparable to high-volume centers. PBD can significantly increase operative time, hospital stay, and morbidity.

Comparison of antimicrobial therapy termination in febrile and afebrile patients with acute cholangitis after drainage.

The standard treatment duration for acute cholangitis (AC) involves a 4-7-day antimicrobial treatment post-biliary drainage; however, recent studies have suggested that a ≤ 2-3 days is sufficient. However, clinical practice frequently depends on body temperature as a criterion for discontinuing antimicrobial treatment. Therefore, in this study, we assessed whether patients with AC can achieve successful outcomes with a ≤ 7-day antimicrobial treatment, even with a fever, assuming the infection source is effectively controlled. We conducted a single-center retrospective study involving patients with AC, defined following the Tokyo Guidelines 2018 for any cause, who underwent successful biliary drainage and completed a ≤ 7-day antimicrobial treatment. Patients were categorized into the febrile and afebrile groups based on their body temperature within 24 h before completing antimicrobial treatment. The primary outcome was the clinical cure rate, defined as no initial presenting symptoms by day 14 post-biliary drainage without recurrence or death by day 30. The secondary outcome was a 3-month recurrence rate. Logistic regression with inverse probability of treatment weighting was used. Overall, 408 patients were selected, among whom 40 (9.8%) were febrile. The two groups showed no significant differences in the clinical cure and 3-month recurrence rates. Notably, the subgroups limited to patients with a ≤ 3-day antibiotic treatment duration also showed no differences in these outcomes. Therefore, our results suggest that discontinuing antibiotics within the initially planned treatment period was sufficient for successful drainage cases of AC, regardless of the patient's fever status during the 24 h leading up to termination.

Study protocol of the FRENCH24-ANIS study: postoperative anti-infective strategy following pancreaticoduodenectomy in patients with preoperative biliary stents-an intergroup FRENCH-ACHBT-SFAR prospective randomized controlled trial.

BACKGROUND: Despite advances in surgical techniques and care, pancreatoduodenectomy (PD) continues to have high morbidity and mortality rates. Complications such as sepsis, hemorrhage, pulmonary issues, shock, and pancreatic fistula are common postoperative challenges. A key concern in PD outcomes is the high incidence of infectious complications, especially surgical site infections (SSI) and postoperative pancreatic fistula (POPF). Bacteriobilia, or bile contamination with microorganisms, significantly contributes to these infections, increasing the risk of early postoperative complications. The occurrence of SSI in patients who undergo hepatobiliary and pancreatic (HPB) surgeries such as PD is notably higher than that in patients who undergo other surgeries, with rates ranging from 20 to 55%. Recent research by D'Angelica et al. revealed that, compared to cefoxitin, piperacillin/tazobactam considerably lowers the rate of postoperative SSI. However, these findings do not indicate whether extending the duration of antibiotic treatment is beneficial for patients at high risk of bacterial biliary contamination. In scenarios with a high risk of SSI, the specific agents, doses and length of antibiotic therapy remain unexplored. The advantage of prolonged antibiotic prophylaxis following PD has not been established through prospective studies in PD patients following biliary drainage. METHODS: This is an intergroup FRENCH-ACHBT-SFAR multicenter, open-labelled randomized, controlled, superiority trial comparing 2 broad-spectrum antibiotic (piperacillin/tazobactam) treatment modalities to demonstrate the superiority of 5-day postoperative antibiotic therapy to antibiotic prophylaxis against the occurrence of surgical site infections (SSI) following pancreaticoduodenectomy in patients with preoperative biliary stents. The primary endpoint of this study is the overall SSI rate, defined according to the ACS NSQIP, as a composite of superficial SSI, deep incisional SSI, and organ/space SSI. In addition, we will analyze overall morbidity, antibiotic resistance profiles, the pathogenicity of bacteriological and fungal cocontamination, the impact of complications after bile drainage and neoadjuvant treatment on the bacteriological and fungal profile of biliculture and cost-effectiveness. CONCLUSION: This FRENCH24-ANIS study aims to evaluate 5-day post-operative antibiotic therapy combined with antibiotic prophylaxis on the occurrence of surgical site infections (SSI) following pancreaticoduodenectomy in patients with preoperative biliary stents. TRIAL REGISTRATION: ClinicaTrials.gov number, NCT06123169 (Registration Date 08-11-2023); EudraCT number 2021-006991-18; EUCT Number: 2024-515181-14-00.