Cavitron ultrasonic surgical aspirator (CUSA) compared with conventional pancreatic transection in distal pancreatectomy: study protocol for the randomised controlled CUSA-1 pilot trial.

BACKGROUND: Postoperative pancreatic fistula (POPF) remains the most common and serious complication after distal pancreatectomy. Many attempts at lowering fistula rates have led to unrewarding insignificant results as still up to 30% of the patients suffer from clinically relevant POPF. Therefore, the development of new innovative methods and procedures is still a cornerstone of current surgical research.The cavitron ultrasonic surgical aspirator (CUSA) device is a well-known ultrasound-based parenchyma transection method, often used in liver and neurosurgery which has not yet been thoroughly investigated in pancreatic surgery, but the first results seem very promising. METHODS: The CUSA-1 trial is a randomised controlled pilot trial with two parallel study groups. This single-centre trial is assessor and patient blinded. A total of 60 patients with an indication for open distal pancreatectomy will be intraoperatively randomised after informed consent. The patients will be randomly assigned to either the control group with conventional pancreas transection (scalpel or stapler) or the experimental group, with transection using the CUSA device. The primary safety endpoint of this trial will be postoperative complications ≥grade 3 according to the Clavien-Dindo classification. The primary endpoint to investigate the effect will be the rate of POPF within 30 days postoperatively according to the ISGPS definition. Further perioperative outcomes, including postpancreatectomy haemorrhage, length of hospital stay and mortality will be analysed as secondary endpoints. DISCUSSION: Based on the available literature, CUSA may have a beneficial effect on POPF occurrence after distal pancreatectomy. The rationale of the CUSA-1 pilot trial is to investigate the safety and feasibility of the CUSA device in elective open distal pancreatectomy compared with conventional dissection methods and gather the first data on the effect on POPF occurrence. This data will lay the groundwork for a future confirmatory multicentre randomised controlled trial. ETHICS AND DISSEMINATION: The CUSA-1 trial protocol was approved by the ethics committee of the University of Heidelberg (No. S-098/2022). Results will be published in an international peer-reviewed journal and summaries will be provided in lay language to study participants and their relatives. TRIAL REGISTRATION NUMBER: DRKS00027474.

Preoperative pancreatic stent placement before the enucleation of insulinoma located in the head and neck of the pancreas in proximity to the main pancreatic duct: study protocol for a multicentre randomised clinical trial in Chinese tertiary medical centres.

INTRODUCTION: The surgical intervention approach to insulinomas in proximity to the main pancreatic duct remains controversial. Standard pancreatic resection is recommended by several guidelines; however, enucleation (EN) still attracts surgeons with less risk of late exocrine/endocrine insufficiency, despite a higher postoperative pancreatic fistula (POPF) rate. Recently, the efficacy and safety of preoperative pancreatic stent placement before the EN have been demonstrated. Thus, a multicentre open-label study is being conducted to evaluate the efficacy and safety of stent placement in improving the outcome of EN of insulinomas in proximity to the main pancreatic duct. METHODS AND ANALYSIS: This is a prospective, randomised, open-label, superiority clinical trial conducted at multiple tertiary centres in China. The major eligibility criterion is the presence of insulinoma located in the head and neck of the pancreas in proximity (≤2 mm) to the main pancreatic duct. Blocked randomisation will be performed to allocate patients into the stent EN group and the direct EN group. Patients in the stent EN group will go through stent placement by the endoscopist within 24 hours before the EN surgery, whereas other patients will receive EN surgery directly. The primary outcome is the assessment of the superiority of stent placement in reducing POPF rate measured by the International Study Group of Pancreatic Surgery standard. Both interventions will be performed in an inpatient setting and regular follow-up will be performed. The primary outcome (POPF rate) will be tested for superiority with the Χ2 test. The difference in secondary outcomes between the two groups will be analysed using appropriate tests. ETHICS AND DISSEMINATION: The study has been approved by the Peking Union Medical College Hospital Institutional Review Board (K23C0195), Ruijin Hospital Ethics Committee (2023-314), Peking University First Hospital Ethics Committee (2024033-001), Institutional Review Board of Xuanwu Hospital of Capital Medical University (2023223-002), Ethics Committee of the First Affiliated Hospital of Xi'an Jiaotong University (XJTU1AF2023LSK-473), Institutional Review Board of Tongji Medical College Tongji Hospital (TJ-IRB202402059), Ethics Committee of Tongji Medical College Union Hospital (2023-0929) and Shanghai Cancer Center Institutional Review Board (2309282-16). The results of the study will be published in an international peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT05523778.

Prophylactic abdominal drainage after distal pancreatectomy (PANDORINA): an international, multicentre, open-label, randomised controlled, non-inferiority trial.

BACKGROUND: Prophylactic passive abdominal drainage is standard practice after distal pancreatectomy. This approach aims to mitigate the consequences of postoperative pancreatic fistula (POPF) but its added value, especially in patients at low risk of POPF, is currently being debated. We aimed to assess the non-inferiority of a no-drain policy in patients after distal pancreatectomy. METHODS: In this international, multicentre, open-label, randomised controlled, non-inferiority trial, we recruited patients aged 18 years or older undergoing open or minimally invasive elective distal pancreatectomy for all indications in 12 centres in the Netherlands and Italy. We excluded patients with an American Society of Anesthesiology (ASA) physical status of 4-5 or WHO performance status of 3-4, added by amendment following the death of a patient with ASA 4 due to a pre-existing cardiac condition. Patients were randomly assigned (1:1) intraoperatively by permuted blocks (size four to eight) to either no drain or prophylactic passive drain placement, stratified by annual centre volume (<40 or ≥40 distal pancreatectomies) and low risk or high risk of grade B or C POPF. High-risk was defined as a pancreatic duct of more than 3 mm in diameter, a pancreatic thickness at the neck of more than 19 mm, or both, based on the Distal Pancreatectomy Fistula Risk Score. Other patients were considered low-risk. The primary outcome was the rate of major morbidity (Clavien-Dindo score ≥III), and the most relevant secondary outcome was grade B or C POPF, grading per the International Study Group for Pancreatic Surgery. Outcomes were assessed up to 90 days postoperatively and analysed in the intention-to-treat population and per-protocol population, which only included patients who received the allocated treatment. A prespecified non-inferiority margin of 8% was compared with the upper limit of the two-sided 95% CI (Wald) of unadjusted risk difference to assess non-inferiority. This trial is closed and registered in the Netherlands Trial Registry, NL9116. FINDINGS: Between Oct 3, 2020, and April 28, 2023, 376 patients were screened for eligibility and 282 patients were randomly assigned to the no-drain group (n=138; 75 [54%] women and 63 [46%] men) or the drain group (n=144; 73 [51%] women and 71 [49%] men). Seven patients in the no-drain group received a drain intraoperatively; consequently, the per-protocol population included 131 patients in the no-drain group and 144 patients in the drain group. The rate of major morbidity was non-inferior in the no-drain group compared with the drain group in the intention-to-treat analysis (21 [15%] vs 29 [20%]; risk difference -4·9 percentage points [95% CI -13·8 to 4·0]; pnon-inferiority=0·0022) and the per-protocol analysis (21 [16%] vs 29 [20%]; risk difference -4·1 percentage points [-13·2 to 5·0]; pnon-inferiority=0·0045). Grade B or C POPF was observed in 16 (12%) patients in the no-drain group and in 39 (27%) patients in the drain group (risk difference -15·5 percentage points [95% CI -24·5 to -6·5]; pnon-inferiority<0·0001) in the intention-to-treat analysis. Three patients in the no-drain group died within 90 days; the cause of death in two was not considered related to the trial. The third death was a patient with an ASA score of 4 who died after sepsis and a watershed cerebral infarction at second admission, leading to multiple organ failure. No patients in the drain group died within 90 days. INTERPRETATION: A no-drain policy is safe in terms of major morbidity and reduced the detection of grade B or C POPF, and should be the new standard approach in eligible patients undergoing distal pancreatectomy. FUNDING: Ethicon UK (Johnson & Johnson Medical, Edinburgh, UK).

Proposal of the novel predictive model for postoperative pancreatic fistula in distal pancreatectomy for pancreatic tumor based on preoperative imaging parameters and stapler handling.

BACKGROUND: Distal pancreatectomy (DP) using linear staplers is widely performed; however, postoperative pancreatic fistulas (POPF) remain an issue. This study aimed to analyze preoperative risk factors for POPF and assess stapler handling. METHODS: We retrospectively analyzed consecutive patients who underwent DP for pancreatic tumors using a linear stapler between 2014 and 2022. Preoperative measurements included pancreas-to-muscle signal intensity ratio (SIR) on fat-suppressed T1-weighted magnetic resonance imaging (MRI). The main outcome was clinically relevant POPF of the 2016 International Study Group of Pancreatic Fistulas definition. The predictive ability of the model was compared with the distal fistula risk score (D-FRS) by using the area under the receiver operating characteristic curve (AUROC). RESULTS: Among the 81 patients, POPF occurred in 31 (38.2%). Multivariate analysis identified computed tomography-measured pancreatic thickness (odds ratio [OR] 1.30, 95% confidence interval [CI] 1.05-1.61, p = 0.009) and SIR on T1-weighted MRI (OR 6.85, 95% CI 1.71-27.4, p = 0.002) as preoperative predictors. A novel preoperative model, "Thickness × MRI (TM)"-index, was established by multiplying these two variables. The TM-index exhibited the highest predictability preoperatively (AUROC 0.757, 95% CI 0.649-0.867). In the intraoperative variable analyses, TM-index (p < 0.001), thin cartridge application (p = 0.032), and short pre-firing compression (p = 0.047) were identified as significant risk factors for POPF. The model's AUROC combined with these two stapler handling methods was higher than D-FRS (0.851 vs. 0.660, p = 0.006). CONCLUSIONS: The novel preoperative model exhibited excellent predictability. Thick cartridge use and long pre-firing compression were protective factors against POPF. This model may facilitate preventive surgical strategy development to reduce POPF.

Hand-sewn gastrojejunal anastomosis reduces delayed gastric emptying after pancreaticoduodenectomy: A single-center retrospective clinical study of 1,077 consecutive patients.

BACKGROUND: Hand-sewn anastomosis and stapled anastomosis are the 2 main types of gastrojejunal anastomotic methods in pancreaticoduodenectomy. There is ongoing debate regarding the most effective anastomotic method for reducing delayed gastric emptying after pancreaticoduodenectomy. This study aims to identify factors that influence delayed gastric emptying after pancreaticoduodenectomy and assess the impact of different anastomotic methods on delayed gastric emptying. METHODS: The study included 1,077 patients who had undergone either hand-sewn anastomosis (n = 734) or stapled anastomosis (n = 343) during pancreaticoduodenectomy between December 2016 and November 2021 at our department. We retrospectively analyzed the clinical data, and a 1:1 propensity score matching was performed to balance confounding variables. RESULTS: After propensity score matching, 320 patients were included in each group. Compared with the stapled anastomosis group, the hand-sewn anastomosis group had a significantly lower incidence of delayed gastric emptying (28 [8.8%] vs 55 [17.2%], P = .001) and upper gastrointestinal tract bleeding (6 [1.9%] vs 17 [5.3%], P = .02). Additionally, the hand-sewn anastomosis group had a significantly reduced postoperative length of stay and lower hospitalization expenses. However, the hand-sewn anastomosis group had a significantly longer operative time, which was consistent with the analysis before propensity score matching. Logistic regression analysis showed that stapled anastomosis, intra-abdominal infection, and clinically relevant postoperative pancreatic fistula were independent prognostic factors for delayed gastric emptying. CONCLUSION: Hand-sewn anastomosis was associated with a lower incidence rate of clinically relevant delayed gastric emptying after pancreaticoduodenectomy. Stapled anastomosis, intra-abdominal infection, and clinically relevant postoperative pancreatic fistula could increase the incidence of postoperative clinically relevant delayed gastric emptying. Hand-sewn anastomosis should be considered by surgeons to reduce the occurrence of postoperative delayed gastric emptying and improve patient outcomes.

Extended pancreatic neck transection versus conventional pancreatic neck transection during laparoscopic pancreaticoduodenectomy (LPDEXCEPT): protocol for a multicentre superiority randomised controlled trial.

INTRODUCTION: Postoperative pancreatic fistula (POPF) remains one of the most severe complications of laparoscopic pancreaticoduodenectomy (LPD). Theoretically, transecting the pancreatic neck more distally has both advantages (more blood supply, and more central pancreatic duct) and disadvantages (maybe smaller the pancreatic duct) in preventing POPF. This theoretical contradiction pushed us to organise this trial to explore the impact of the level of pancreatic transection in clinical practice. We conduct this randomised trial with the hypothesis that extended pancreatic neck transection has superiority to conventional pancreatic neck transection. METHODS AND ANALYSIS: The LPDEXCEPT (Extended pancreatic neck transection versus conventional pancreatic neck transection during laparoscopic pancreaticoduodenectomy) trial is a multicentre, randomised-controlled, open-label, superiority trial in 4 centres whose annual surgical volume for LPD is more than 25 cases with pancreatic surgeons who had completed their learning curve. A total of 154 patients who meet the inclusive and exclusive criteria are randomly allocated to the extended pancreatic neck transection group or conventional pancreatic neck transection group in a 1:1 ratio. The stratified randomised block design will be applied, with stratified factors are surgical centre and the diameter of the main pancreatic duct measured by preoperative CT scan (preMPD). The primary outcome is the incidence of the clinically relevant pancreatic fistula. ETHICS AND DISSEMINATION: Ethics Committee on Biomedical Research of West China Hospital of Sichuan University has approved this trial in March 2023 (approval no. 2023-167). Results of this trial will be published in peer-reviewed journals and conference proceedings. TRIAL REGISTRATION NUMBER: NCT05808894.

Pancreatic stump closure after distal pancreatectomy: Systematic review and meta-analysis of randomized clinical trials comparing non-autologous versus no reinforcement: Value of prediction intervals.

BACKGROUND: This meta-analysis of randomized trials aimed to assess the benefits and harms of non-autologous versus no reinforcement of the pancreatic stump following distal pancreatectomy (DP). METHODS: It was performed in accordance with PRISMA 2020 and AMSTAR 2 Guidelines. (registered in PROSPERO ID: EROCRD42021286863). RESULTS: Nine relevant articles (between 2009 and 2021) were retrieved, comparing non-autologous reinforcement (757 patients) with non-reinforcement (740 patients) after PD. Pooled analysis showed a statistically significant lower rate of postoperative pancreatic fistula (POPF) in the reinforcement group (RR â€‹= â€‹0.677; 95 â€‹% CI [0.479, 0.956], p â€‹= â€‹0.027). The 95 â€‹% predictive interval (0.267-1.718) showed heterogeneity. Non-autologous reinforcement other than with "Tachosil®" was effective (subgroup analysis). No statistically significant differences were found between the two groups with regard to secondary outcomes. CONCLUSIONS: This meta-analysis showed that covering the stump with non-autologous reinforcement other than Tachosil® had a preventive effect on the onset of POPF.

Comparison of manual sutures and laparoscopic stapler for pancreatic stump closure techniques in robotic distal pancreatectomy: a single-center experience.

BACKGROUND: Postoperative pancreatic fistulas (POPFs) are prevalent and major postoperative complications of distal pancreatectomy (DP). There are numerous ways to manage the pancreatic stump. However, no single approach has been shown to be consistently superior. Moreover, the potential role of robotic systems in reducing POPFs has received little attention. METHODS: The clinical data of 119 patients who had consecutively received robotic distal pancreatectomy between January 2019 and December 2022 were retrospectively analyzed. Patients were divided into two groups according to the method of handling the pancreatic stump. The attributes of the patients and the variables during the perioperative period were compared. RESULTS: The analysis included 72 manual sutures and 47 stapler procedures. The manual suture group had a shorter operative time (removing installation time) than the stapler group (125.25 ± 63.04 min vs 153.30 ± 62.03 min, p = 0.019). Additionally, the manual suture group had lower estimated blood loss (50 mL vs 100 mL, p = 0.009) and a shorter postoperative hospital stay. There were no significant differences in the incidence of clinically relevant POPFs between the two groups (18.1% vs 23.4%, P > 0.05). No perioperative death occurred in either group. CONCLUSION: The manual suturing technique was shown to have an incidence of POPFs similar to the stapler technique in robotic distal pancreatectomy and to be safe and feasible.

Dual-crosslinking immunostimulatory hydrogel synchronously suppresses pancreatic fistula and pancreatic cancer relapse post-resection.

In pancreatic cancer (PC), surgical resection remains the sole curative option, albeit patients undergoing resection are susceptible to postoperative pancreatic fistula (PF) formation and tumor recurrence. An unmet need exists for a unified strategy capable of concomitantly averting PF and tumor relapse to mitigate morbidity in PC patients after surgery. Herein, an original dual crosslinked biological sealant hydrogel (methacrylate-hyaluronic acid-dopamine (MA-HA-DA) and sulfhydryl-hyaluronic acid-dopamine (SH-HA-DA)) was engineered as a drug depot and loaded with polydopamine-cloaked cytokine interleukin-15 and platelets conjugated with anti-TIGIT. In vitro analyses validated favorable tissue adhesion, cytocompatibility, and stability of the hydrogels. In a PF rodent model, the hydrogel effectively adhered to the pancreatic stump, sealing the severed pancreatic end and impeding post-operative elevations in amylase and lipase. In PC murine models, hydrogels potently stimulated CD8+ T and NK cells to deter residual tumor re-growth and distant metastasis. This innovative hydrogel strategy establishes a new framework for concomitant prevention of PF and PC recurrence.

Efficacy of rectal indomethacin in prevention of post-operative hyperamylasemia following pancreatoduodenectomy: a randomized controlled trial.

BACKGROUND: Post-operative hyperamylasemia (POH) following pancreatoduodenectomy (PD) may play a key role in pathogenesis of post-operative pancreatic fistula (POPF). Aim of the current study was to evaluate efficacy of perioperative administration of indomethacin in preventing POH. METHODS: Single-center, double-blind, randomized controlled trial (RCT) conducted on consecutive patients undergoing PD. Patients received either 100 mg of indomethacin per-rectally at induction of anesthesia or standard care. Primary endpoint was incidence of POH in the two arms. POH was defined as postoperative day (POD) 1 serum amylase (S. amylase) levels greater than the upper limit of normal. RESULTS: After exclusion 44 patients were randomized. The two arms were comparable for preoperative and intraoperative parameters. POH was noted in 20/44 (45.5%) with significantly lower incidence of POH (60.9% vs. 28.6%, p = 0.032) in intervention arm (IA). Median S. amylase, POD 1, 3, and 5 drain amylase, and incidence of clinically relevant POPF (CR-POPF) were lower in IA but failed to reach statistical significance (30.4% vs. 14.3%, p = 0.18). The severity of delayed gastric emptying (DGE) was significantly lower in the IA (grade B/C DGE 23.8% vs. 47.8%, p = 0.023). Evaluation of risk factors for POH showed IA to confer an independent protective effect and increased risk with soft pancreas. CONCLUSION: Perioperative per-rectal indomethacin administration is effective in decreasing the incidence of POH following pancreatoduodenectomy.

Nationwide validation of the distal fistula risk score (D-FRS).

PURPOSE: Distal pancreatectomy (DP) is associated with a high complication rate of 30-50% with postoperative pancreatic fistula (POPF) as a dominant contributor. Adequate risk estimation for POPF enables surgeons to use a tailor-made approach. Assessment of the risk of POPF prior to DP can lead to the application of preventive strategies. The current study aims to validate the recently published preoperative and intraoperative distal fistula risk score (D-FRS) in a nationwide cohort. METHODS: This nationwide retrospective Dutch cohort study included all patients after DP for any indication, all of whom were registered in the Dutch Pancreatic Cancer Audit (DPCA) database between 2013 and 2021. The D-FRS was validated by filling in the probability equations with data from this cohort. The predictive capacity of the models was represented by an area under the receiver operating characteristic (AUROC) curve. RESULTS: A total of 896 patients underwent DP of which 152 (17%) developed POPF of whom 144 grade B (95%) and 8 grade C (5%). The preoperative D-FRS, consisting of the variables pancreatic neck thickness and pancreatic duct diameter, showed an AUROC of 0.73 (95%CI 0.68-0.78). The intraoperative D-FRS, comprising pancreatic neck, duct diameter, BMI, operating time, and soft pancreatic aspect, showed an AUROC of 0.69 (95%CI 0.64-0.74). CONCLUSION: The current study is the first nationwide validation of the preoperative and intraoperative D-FRS showing acceptable distinguishing capacity for only the preoperative D-FRS for POPF. Therefore, the preoperative score could improve prevention and mitigation strategies such as drain management, which is currently investigated in the multicenter PANDORINA trial.

Retroperitonealization of the pancreatic stump in distal pancreatectomy: a novel technique to reduce postoperative pancreatic fistula.

PURPOSE: To evaluate the efficacy and safety of retroperitonealization of the pancreatic stump in distal pancreatectomy. METHODS: Clinical data from the Tongji Hospital pancreatic database were retrospectively reviewed in this study. The data of 68 patients who underwent retroperitonealized distal pancreatectomy from January, 2019, to April, 2021, were collected and analyzed. Sixty-four patients who underwent conventional distal pancreatectomy during the same period were matched. We compared and analyzed the operative outcomes and postoperative complications between the patients in the two groups before and after propensity score matching (PSM). RESULTS: Before PSM, the operative outcomes and postoperative complications were comparable between the two groups. After PSM, the retroperitonealized group had a lower incidence of postoperative pancreatic fistula (POPF) (10.53% vs 31.58%, P = 0.047) and shorter time until drainage removal (10.00, 8.00-13.00 days vs 13.00, 10.00-18.00 days, P = 0.005). In the univariate and multivariate regression analyses, non-retroperitonealization and intra-abdominal infection were found to be independent risk factors for postoperative pancreatic fistula (POPF). CONCLUSION: Retroperitonealization of the pancreatic stump can reduce the incidence of POPF after distal pancreatectomy.

The cholinesterase and C-reactive protein score is a potential predictor of pseudoaneurysm formation after pancreaticoduodenectomy in patients with soft pancreas.

BACKGROUND: Pseudoaneurysm (PA) rupture after pancreaticoduodenectomy (PD) is a life-threatening complication. Most PA cases originate from postoperative pancreatic fistulas (POPFs). Although several risk factors for POPF have been identified, specific risk factors for PA formation remain unclear. Therefore, we retrospectively analyzed PD cases with soft pancreas and proposed a novel strategy for early detection of PA formation. METHODS: Overall, 120 patients underwent PD between 2010 and 2020 at our institution; of these, 65 patients with soft pancreas were enrolled. We evaluated the clinicopathological factors influencing PA formation and developed a risk score to predict PA formation. RESULTS: In total, 11 of the 65 patients developed PAs (PA formation group: PAG), and 8 of these 11 PAs ruptured. The median time to PA formation was 15 days, with a minimum of 5 days. The PAG was significantly older than the non-PA formation group, were predominantly men, and had comorbid diabetes mellitus. Pre- and intra-operative findings were similar between the two groups. Importantly, no significant differences were found in postoperative drain amylase levels and total drain amylase content. Cholinesterase and C-reactive protein (CRP) levels on postoperative day (POD) 3 were significantly different between the two groups. Multivariate analysis showed that cholinesterase ≤ 112 U/L and CRP ≥ 16.0 mg/dl on POD 3 were independent predictors of PA formation. CONCLUSIONS: Decreased cholinesterase and elevated CRP on POD 3 (Cho-C score) are useful predictors of PA formation in cases with soft pancreas. In such cases, periodic computed tomography evaluations and strict drain management are necessary to prevent life-threatening hemorrhage.

Effect of main pancreatic duct suture ligation on the prevention of clinically relevant pancreatic fistula after distal pancreatectomy: analysis of 82 consecutive patients.

OBJECTIVE: This study aimed to examine the factors linked to the development of clinically significant pancreatic fistulas following distal pancreatectomy (DP) and to assess the efficacy of suture ligation of the main pancreatic duct. PATIENTS AND METHODS: A single-center retrospective study was performed on the medical records of 82 patients who underwent DP in our institution between January 2011 and December 2019. RESULTS: There were 28 males (34.1%) and 54 females (65.9%). The patients' age ranged from 18 to 86 years (median: 55.5 years). Indications for DP included primary pancreatic disease (n=63, 76.8%) and non-pancreatic disease (n=19, 23.2%). Postoperative mortality and morbidity rates were 3.7% and 48%, respectively. Pancreatic parenchymal closure was accomplished by a hand-sewn technique or mechanical stapling in 89 and 13 patients, respectively. Identification of the pancreatic duct and suture ligation was performed in 46 patients (56.1%). Pancreatic fistula was developed in 20 patients (24.4%); 12 fistulas were classified as Grade B, and 8 as Grade C. Biochemical leaks (Grade A) were identified in 8 patients (9.8%). Multivariate analysis indicated that failure to ligate the main pancreatic duct was the only variable associated with an increased risk for pancreatic leak (p=0.031; odds ratio=0.233; 95% confidence interval, 0.062-0.879). CONCLUSIONS: Pancreatic leak remains a common complication after DP. The incidence of leaks is reduced significantly when the main pancreatic duct is identified and directly ligated during DP.

Wrapping pancreaticojejunostomy using the ligamentum teres hepatis during laparoscopic pancreaticoduodenectomy: a propensity score matching analysis.

BACKGROUND AND OBJECTIVE: It is controversial whether wrapping around the pancreaticojejunostomy (PJ) could reduce the rate of postoperative pancreatic fistula (POPF), especially in laparoscopic pancreaticoduodenectomy (LPD). This study aims to summarize our single-center initial experience in wrapping around PJ using the ligamentum teres hepatis (LTH) and demonstrate the feasibility and safety of this method. METHODS: Patients who underwent LPD applying the procedure of wrapping around the PJ were identified. The cohort was compared to the cohort with standard non-wrapping PJ. A 1:1 propensity score matching (PSM) was performed to compare the early postoperative outcomes of the two cohorts. Risk factors for POPF were determined by using univariate and multivariate logistic regression analysis. RESULTS: Overall, 143 patients were analyzed (LPD without wrapping (n = 91) and LPD with wrapping (n = 52)). After 1:1 PSM, 48 patients in each cohort were selected for further analysis. Bile leakage, DGE, intra-abdominal infection, postoperative hospital stays, harvested lymph nodes, and R0 resection were comparable between the two cohorts. However, the wrapping cohort was associated with significantly less POPF B (1 vs 18, P = 0.003), POPF C (0 vs 8, P = 0.043), and Clavien-Dindo classification level III-V (5 vs 26, P = 0.010). No patients died due to the clinically relevant POPF in the two cohorts. No patients who underwent the LTH wrapping procedure developed complications directly related to the wrapping procedure. After PSM, whether wrapping was an independent risk factor for POPF (OR = 0.202; 95%CI:0.080-0.513; P = 0.001). CONCLUSIONS: Wrapping the LTH around the PJ technique for LPD was safe, efficient, and reproducible with favorable perioperative outcomes in selected patients. However, further validations using high-quality RCTs are still required to confirm the findings of this study.

Reinforced stapling does not reduce postoperative pancreatic fistula in distal pancreatectomy: a systematic review and meta-analysis.

Postoperative pancreatic fistula (POPF) is a severe complication after distal pancreatectomy (DP); however, it is unclear how to effectively reduce the incidence. The purpose of this meta-analysis is to determine whether reinforced stapling reduces POPF after DP. From February 2007 to April 2023, a comprehensive search of electronic data and references was conducted in PubMed/Medline, Embase, Web of Science, the Cochrane Central Register of Controlled Trials, and the Cochrane Database of Systematic Reviews. In this study, the perioperative outcomes were evaluated for the reinforced stapler (RS) group and the standard stapler (SS) group in DP using Review Manager Software. Using fixed- or random-effects models, pooled odds ratios (ORs) and mean differences (MDs) with 95% confidence intervals (CIs) were calculated. In total, three randomized clinical trials (RCTs) with 425 patients and five observational clinical studies (OCS) with 318 patients were included. In pooled meta-analyses from RCTs, there was no difference between the two groups in the incidence of POPF (OR = 0.79; 95% CI [0.47,1.35]; P = 0.39), intraoperative blood loss (MD = 10.66; 95% CI [- 28.83,50.16]; P = 0.6), operative time (MD = 9.88; 95% CI [- 8.92,28.67]; P = 0.3), major morbidity (OR = 1.12; 95% CI [0.67,1.90]; P = 0.66), reoperation (OR = 0.97; 95% CI [0.41,2.32]; P = 0.95), readmission (OR = 0.99; 95% CI [0.57,1.72]; P = 0.97) or hospital stay (MD = - 0.95; 95% CI [- 5.22,3.31]; P = 0.66). However, the results of POPF and readmission were favorable for RS in the OCS group.

Postoperative computed tomography findings predict re-drainage cases after early drain removal in pancreaticoduodenectomy.

PURPOSE: This study aimed to investigate the risk factors for re-drainage in patients with early drain removal after pancreaticoduodenectomy (PD). METHODS: This study retrospectively analyzed 114 patients who underwent PD and prophylactic drain removal on postoperative day (POD) 4 between January 2012 and March 2021. We analyzed the risk factors for re-drainage according to various factors. Peri-pancreaticojejunostomic fluid collection (PFC) index and pancreatic cross-sectional area (CSA) were evaluated using computed tomography on POD 4. The PFC index was calculated by multiplying the length, width, and height at the maximum aspect. RESULTS: Among the 114 patients, 15 (13%) underwent re-drainage due to postoperative pancreatic fistula. Multivariate analysis identified a PFC index ≥ 8.16 cm3 on POD 4 (odds ratio [OR], 20.40, 95%CI 2.38-174.00; p = 0.006) and pancreatic CSA on POD 4 ≥ 3.65 cm2 (OR, 16.40, 95%CI 1.57-171.00; p = 0.020) as independent risk factors for re-drainage. CONCLUSION: A careful decision might be necessary for early drain removal in patients with a PFC index ≥ 8.16 cm3 and pancreatic CSA ≥ 3.65 cm2.

Application of an innovative pancreaticojejunostomy technique with a modified set of perioperative management in pancreatoduodenectomy: a retrospective cohort study.

How to reduce grade C postoperative pancreatic fistula (POPF) incidence after pancreaticoduodenectomy (PD) is the pursuit of pancreatic surgeons. This study introduced an innovative pancreaticojejunostomy (PJ) technique with a complete set of perioperative management. All 144 patients in this single-center retrospective cohort study underwent the same PJ technique and perioperative management. The primary endpoint was grade C POPF incidence. The secondary endpoints were grade B POPF rate, drain fluid amylase level, complications, hospital stay duration, and mortality. Risk factors for clinically-relevant POPF (CR-POPF) were assessed by logistic regression analysis. No patient (0.0%) experienced grade C POPF, while 44 (30.6%) developed grade B. No in-hospital death was recorded. Multivariate analysis found relatively high body mass index, laparoscopic surgery, and soft or moderate pancreatic texture independent risk factors for CR-POPF. Our novel PJ anastomosis with modified perioperative management helped avoid grade C POPF. However, grade B POPF incidence was relatively high to some extent because of the enhanced management itself.