One hundred consecutive pancreatic resections using a novel pancreatico-jejunostomy technique.

BACKGROUND: No single technique of remnant pancreas reconstruction after pancreaticoduodenectomy (PD) has been demonstrated to be superior to the others in the prevention of post-operative pancreatic fistula (POPF), and the accumulation of surgical experience is closely related to the quality of this anastomosis. The aim of the current study was to evaluate the feasibility and patient outcomes of a simplified technique involving a single-layer continuous pancreaticojejunostomy (PJA) with Falciform ligament reinforcement that can be used with all types of pancreases. METHODS: A single-centre and single-surgeon study was performed. One hundred consecutive patients undergoing pancreatic resection with subsequent PJA using a novel technique performed by a single surgeon were included in the study. Patient demographics, pre-operative treatments, risk factors for POPF, and post-operative morbidity and mortality and long-term patient outcome were prospectively recorded and reported. RESULTS: From March 2018 to March 2022, 59 male and 41 female patients were included. 91 patients underwent PD for malignancy with 32 receiving neoadjuvant treatment. 59 patients were classified as intermediate/high risk for POPF according to validated fistula prediction models. There were 12 POPF Type B and 2 POPF Type C. The overall morbidity rate was 16% with no 90-day mortality. 3 patients underwent reoperation. The median length of hospitalisation was 12.6 days and 82% of eligible patients commenced and completed adjuvant chemotherapy. CONCLUSION: Single-layer continuous dunking PJA with Falciform ligament reinforcement is a simplified and feasible method for PJA with a low associated complication rate.

[Our innovations for the reduction of postoperative pancreatic fistula output]. / A posztoperatív pancreasfistula csökkentésére bevezetett innovációink.

Bevezetés: A posztoperatív pancreasfistula mind proximalis, mind distalis pancreatectomia után a legjelentosebb sebészi szövodménynek számít. A szakirodalomban nincs egyértelmuen ajánlott, megbízható módszer ezen probléma kiküszöbölésére, emiatt történnek újítások szerte a világon. Jelen közleményünkben a technikai innovációinkról számolunk be. Anyag és módszerek: 2013. január 1-jétol 2023. november 30-ig terjedo idoszakban 205 Whipple-mutétet végeztünk nyitottan, mely során a pancreatojejunalis anastomosist az általunk módosított dohányzacskó-öltéses módszerrel készítettük el. 2019. január 1. és 2023. november 30. között pedig 30 betegnél történt nyitott distalis pancreatectomia, amikor a pancreascsonkot az általunk kifejlesztett technikával, szabad rectus fascia-peritoneum grafttal fedtük, majd azt cirkuláris öltéssel rögzítettük. Közleményünkben ezen két módszerrel elért eredményeket ismertetjük. Eredmények: a demográfiai adatok megfeleltek a betegségnél szokásosnak. A posztoperatív ápolási ido és a transzfúzió igény terén észlelt különbségek tükrözték a kétféle beavatkozás eltéro invazivitását. A releváns pancreasfistula kialakulási rátája kedvezo képet mutatott, Whipple-mutét után 7,3% volt, míg distalis pancreatectomát követoen nem fejlodött ki. A reoperációs és a halálozási arányok megfeleltek az elvártaknak és korreláltak a mutétek kiterjedtségével. Következtetés: pancreas resectiók utáni komplikációk csökkentésére tett törekvéseink során a módosított dohányzacskó-öltéses pancreatojejunostomia és a pancreascsonk fedésére kidolgozott módszerünk egyaránt kedvezo eredményekkel járt.

Omental Flap Technique in Pancreaticojejunostomy: Does it Prevent Pancreatic Fistula Development after Pancreaticoduodenectomy?

AIM: The aim of our study was to investigate the clinical results of omental flap application during pancreaticojejunostomy (PJ) anastomosis in pancreatoduodenectomy (PD) surgeries. METHODS: The data of patients who underwent pancreaticoduodenectomy in our hospital were evaluated retrospectively. The patients were divided into two groups; patients with an omental flap (Group 1) and those without an omental flap (Group 2). The demographic and other characteristics of the groups and the incidence of postoperative pancreatic fistula (POPF) development were compared. RESULTS: One hundred patients were included (39 females, 61 males) Group 1 consisted of 20 patients with omental flaps and Group 2 consisted of 80 patients without omental flaps. While no clinically significant (Grade B and C) leaks were observed in Group 1, both biochemical and clinically significant leak rates were lower in Group 1 compared to 4 patients (5%) in Group 2. There was no statistically significant difference compared with Group 2 (p > 0.05). CONCLUSIONS: Although not statistically significant in this study, postoperative complication rates and the incidence of POPF tended to decrease in patients who underwent omental flaps.

Prolonged pre-firing pancreatic compression with linear staplers in distal pancreatectomy: a valuable technique for post-operative pancreatic fistula prevention.

PURPOSE: Post-operative pancreatic fistula (POPF) remains the main complication after distal pancreatectomy (DP). The aim of this study is to evaluate the potential benefit of different durations of progressive stapler closure on POPF rate and severity after DP. METHODS: Patients who underwent DP between 2016 and 2023 were retrospectively enrolled and divided into two groups according to the duration of the stapler closure: those who underwent a progressive compression for < 10 min and those for ≥ 10 min. RESULTS: Among 155 DPs, 83 (53.5%) patients underwent pre-firing compression for < 10 min and 72 (46.5%) for ≥ 10 min. As a whole, 101 (65.1%) developed POPF. A lower incidence rate was found in case of ≥ 10 min compression (34-47.2%) compared to < 10 min compression (67- 80.7%) (p = 0.001). When only clinically relevant (CR) POPFs were considered, a prolonged pre-firing compression led to a lower rate (15-20.8%) than the < 10 min cohort (32-38.6%; p = 0.02). At the multivariate analysis, a compression time of at least 10 min was confirmed as a protective factor for both POPF (OR: 5.47, 95% CI: 2.16-13.87; p = 0.04) and CR-POPF (OR: 2.5, 95% CI: 1.19-5.45; p = 0.04) development. In case of a thick pancreatic gland, a prolonged pancreatic compression for at least 10 min was significantly associated to a lower rate of CR-POPF compared to < 10 min (p = 0.04). CONCLUSION: A prolonged pre-firing pancreatic compression for at least 10 min seems to significantly reduce the risk of CR-POPF development. Moreover, significant advantages are documented in case of a thick pancreatic gland.

Thirty-day prevalence and clinical impact of fluid collections at the resection margin after distal pancreatectomy: Follow-up of a multicentric randomized controlled trial.

BACKGROUND: Postoperative fluid collections at the resection margin of the pancreatic stump are frequent after distal pancreatectomy, yet their clinical impact is unclear. The aim of this study was to assess the 30-day prevalence of postoperative fluid collections after distal pancreatectomy and the factors associated with a clinically relevant condition. METHODS: Patients enrolled in a randomized controlled trial of parenchymal transection with either reinforced, triple-row staple, or ultrasonic dissector underwent routine magnetic resonance 30 days postoperatively. Postoperative fluid collection was defined as a cyst-like lesion of at least 1 cm at the pancreatic resection margin. Postoperative fluid collections requiring any therapy were defined as clinically relevant. RESULTS: A total of 133 patients were analyzed; 69 were in the triple-row staple transection arm, and 64 were in the ultrasonic dissector transection arm. The overall 30-day prevalence of postoperative fluid collections was 68% (n = 90), without any significant difference between the two trial arms. Postoperative serum hyperamylasemia was more frequent in patients with postoperative fluid collections than those without (31% vs 7%, P = .001). Among the postoperative fluid collection population, an early postoperative pancreatic fistula (odds ratio 14.9, P = .002), post pancreatectomy acute pancreatitis (odds ratio 12.7, P = .036), and postoperative fluid collection size larger than 50 mm (odds ratio 6.6, P = .046) were independently associated with a clinically relevant postoperative fluid collection. CONCLUSION: Postoperative fluid collections at the resection margin are common after distal pancreatectomy and can be predicted by early assessment of postoperative serum hyperamylasemia. A preceding pancreatectomy acute pancreatitis and/or postoperative pancreatic fistula and large collections (>50 mm) were associated with a clinically relevant postoperative fluid collection, representing targets for closer follow-up or earlier therapeutic interventions.

Technical details of robotic pancreatojejunostomy using a modified Blumgart anastomosis: Thread manipulation using gauze and an assisted port.

BACKGROUNDS: Pancreatojejunostomy is a technically demanding procedure during robotic pancreaticoduodenectomy (RPD). Modified Blumgart anastomosis (mBA) is a common method for the pancreatojejunostomy; however, the technical details for robotic mBA are not well established. During RPD, we performed a mBA for the pancreatojejunostomy using thread manipulation with gauze and an additional assist port. METHODS: Patients who underwent robotic pancreatoduodenectomy at Fujita Health University from November 2009 to May 2023 were retrospectively investigated, and technical details for the robotic-modified Blumgart anastomosis were demonstrated. RESULTS: Among 78 patients who underwent RPD during the study period, 33 underwent robotic mBA. Postoperative pancreatic fistula (POPF) occurred in six patients (18%). None of the patients suffered POPF Grade C according to the international study group of pancreatic surgery definition. The anastomotic time for mBA was 80 min (54-125 min). CONCLUSION: Robotic mBA resulted in reasonable outcomes. We propose that mBA could be used as one of the standard methods for robotic pancreatojejunosotomy.

Effect of artificial or autologous coverage of the pancreatic remnant or anastomosis on postoperative pancreatic fistulas after partial pancreatectomy: meta-analysis of randomized clinical trials.

BACKGROUND: Postoperative pancreatic fistulas remain a driver of major complications after partial pancreatectomy. It is unclear whether coverage of the anastomosis or pancreatic remnant can reduce the incidence of postoperative pancreatic fistulas. The aim of this study was to evaluate the effect of autologous or artificial coverage of the pancreatic remnant or anastomosis on outcomes after partial pancreatectomy. METHODS: A systematic literature search was performed using MEDLINE and the Cochrane Central Register of Controlled Trials (CENTRAL) up to March 2024. All RCTs analysing a coverage method in patients undergoing partial pancreatoduodenectomy or distal pancreatectomy were included. The primary outcome was postoperative pancreatic fistula development. Subgroup analyses for pancreatoduodenectomy or distal pancreatectomy and artificial or autologous coverage were conducted. RESULTS: A total of 18 RCTs with 2326 patients were included. In the overall analysis, coverage decreased the incidence of postoperative pancreatic fistulas by 29% (OR 0.71, 95% c.i. 0.54 to 0.93, P < 0.01). This decrease was also seen in the 12 RCTs covering the remnant after distal pancreatectomy (OR 0.69, 95% c.i. 0.51 to 0.94, P < 0.02) and the 4 RCTs applying autologous coverage after pancreatoduodenectomy and distal pancreatectomy (OR 0.53, 95% c.i. 0.29 to 0.96, P < 0.04). Other subgroup analyses (artificial coverage or pancreatoduodenectomy) showed no statistically significant differences. The secondary endpoints of mortality, reoperations, and re-interventions were each affected positively by the use of coverage techniques. The certainty of evidence was very low to moderate. CONCLUSION: The implementation of coverage, whether artificial or autologous, is beneficial after partial pancreatectomy, especially in patients undergoing distal pancreatectomy with autologous coverage.

Retromesenteric omental flap as arterial coverage in pancreaticoduodenectomy: A novel technique to prevent postpancreatectomy hemorrhage.

BACKGROUND: Clinically relevant postpancreatectomy hemorrhage occurs in 10% to 15% of patients after pancreaticoduodenectomy, mainly in association with clinically relevant postoperative pancreatic fistula. Prevention of postpancreatectomy hemorrhage by arterial coverage with a round ligament plasty or an omental flap is controversial. This study assessed the impact of arterial coverage with an original retromesenteric omental flap on postpancreatectomy hemorrhage after pancreaticoduodenectomy. METHODS: This single-center retrospective study included 812 open pancreaticoduodenectomies (2012-2021) and compared 146 procedures with arterial coverage using retromesenteric omental flap to 666 pancreaticoduodenectomies without arterial coverage. The Fistula Risk Score was calculated. The primary endpoint was a 90-day clinically relevant postpancreatectomy hemorrhage rate according to the International Study Group of Pancreatic Surgery classification. RESULTS: There were more patients with a Fistula Risk Score ≥7 in the arterial coverage-retromesenteric omental flap group: 18 (12%) versus 48 (7%) (P < .01). Clinically relevant postpancreatectomy hemorrhage was less frequent in the arterial coverage- retromesenteric omental flap group than in the no arterial coverage group: 5 (3%) versus 66 (10%), respectively (P = .01). Clinically relevant postoperative pancreatic fistula occurred in 28 (19%) patients in the arterial coverage- retromesenteric omental flap group compared with 165 (25%) in the no arterial coverage group (P = .001). There were fewer reoperations for postpancreatectomy hemorrhage or postoperative pancreatic fistula in the arterial coverage- retromesenteric omental flap group: 1 (0.7%) versus 32 (5%) in the no arterial coverage group (P = .023). In multivariate analysis, arterial coverage with retromesenteric omental flap was an independent protective factor of clinically relevant postpancreatectomy hemorrhage (odds ratio 0.33; 95% confidence interval [0.12-0.92], P = .034) whereas postoperative pancreatic fistula of any grade (odds ratio = 10.1; 95% confidence interval: 5.1-20.3, P < .001) was predictive of this complication. CONCLUSION: Arterial coverage with retromesenteric omental flap can reduce rates of clinically relevant postpancreatectomy hemorrhage after pancreaticoduodenectomy. This easy and costless technique should be prospectively evaluated to confirm these results.

Efficacy of Pancreatic Dissection With a Triple-row Stapler in Laparoscopic Distal Pancreatectomy: A Retrospective Observational Study.

BACKGROUND: Postoperative pancreatic fistulas (POPFs) occur after 20% to 30% of laparoscopic distal pancreatectomies. This study aimed to evaluate the clinical efficacy of laparoscopic distal pancreatectomy using triple-row staplers in preventing POPFs. METHODS: Between April 2016 and May 2023, 59 patients underwent complete laparoscopic distal pancreatectomies. There were more females (n=34, 57.6%) than males (n=25, 42.4%). The median age of the patients was 68.9 years. The patients were divided into slow-compression (n=19) and no-compression (n=40) groups and examined for pancreatic leakage. Both groups were examined with respect to age, sex, body mass index (BMI), pancreatic thickness at the pancreatic dissection site, pancreatic texture, diagnosis, operative time, blood loss, presence of POPF, date of drain removal, and length of hospital stay. In addition, risk factors for POPF were examined in a multivariate analysis. RESULTS: Grade B POPFs were found in 9 patients (15.3%). Using univariate analysis, the operative time, blood loss, postoperative pancreatic fluid leakage, day of drain removal, and hospital stay were shorter in the no-compression group than in the slow-compression group. Using multivariate analysis, the absence of POPFs was significantly more frequent in the no-compression group (odds ratio, 5.69; 95% CI, 1.241-26.109; P =0.025). The no-compression pancreatic dissection method was a simple method for reducing POPF incidence. CONCLUSIONS: The method of quickly dissecting the pancreas without compression yielded better results than the method of slowly dissecting the pancreas with slow compression. This quick dissection without compression was a simple and safe method that minimized postoperative pancreatic fluid leakage, shortened the operative time and length of hospital stay, and reduced medical costs. Therefore, this method might be a clinically successful option.

Safety and effectiveness of minimally invasive central pancreatectomy versus open central pancreatectomy: a systematic review and meta-analysis.

BACKGROUND: Central pancreatectomy is a surgical procedure for benign and low-grade malignant tumors which located in the neck and proximal body of the pancreas that facilitates the preservation of pancreatic endocrine and exocrine functions but has a high morbidity rate, especially postoperative pancreatic fistula (POPF). The aim of this systematic review and meta-analysis was to evaluate the safety and effectiveness between minimally invasive central pancreatectomy (MICP) and open central pancreatectomy (OCP) basing on perioperative outcomes. METHODS: An extensive literature search to compare MICP and OCP was conducted from October 2003 to October 2023 on PubMed, Medline, Embase, Web of Science, and the Cochrane Library. Fixed-effect models or random effects were selected based on heterogeneity, and pooled odds ratios (ORs) or mean differences (MDs) with 95% confidence intervals (CIs) were calculated. RESULTS: A total of 10 studies with a total of 510 patients were included. There was no significant difference in POPF between MICP and OCP (OR = 0.95; 95% CI [0.64, 1.43]; P = 0.82), whereas intraoperative blood loss (MD = - 125.13; 95% CI [- 194.77, -55.49]; P < 0.001) and length of hospital stay (MD = - 2.86; 95% CI [- 5.00, - 0.72]; P = 0.009) were in favor of MICP compared to OCP, and there was a strong trend toward a lower intraoperative transfusion rate in MICP than in OCP (MD = 0.34; 95% CI [0.11, 1.00]; P = 0.05). There was no significant difference in other outcomes between the two groups. CONCLUSION: MICP was as safe and effective as OCP and had less intraoperative blood loss and a shorter length of hospital stay. However, further studies are needed to confirm the results.

Continuous drain irrigation as a risk mitigation strategy for postoperative pancreatic fistula: a meta-analysis.

BACKGROUND: Postoperative pancreatic fistula serves as the principle cause for the morbidity and mortality observed after pancreatectomy. Continuous drain irrigation as a treatment strategy for infected pancreatic necrosis has previously been described; however, its role adter pancreatectomy has yet to be determined. The aim of this study was to determine whether continuous drain irrigation reduces postoperative pancreatic fistula. METHODS: A meta-analysis of the pre-existing literature was performed. The primary end point was whether continuous drain irrigation reduced postoperative pancreatic fistula after pancreatectomy. The secondary end point evaluated its impact on postoperative morbidity, mortality, and length of stay. RESULTS: Nine articles involving 782 patients were included. Continuous drain irrigation use was associated with a statistically significant reduction in postoperative pancreatic fistula rates (odds ratio [95% confidence interval] 0.40 [0.19-0.82], P = .01). Upon subgroup analysis, a significant reduction in clinically relevant postoperative pancreatic fistula was also noted (odds ratio 0.37 [0.20-0.66], P = .0008). A reduction in postoperative complications was also observed-delayed gastric emptying (0.45 [0.24-0.84], P = .01) and the need for re-operation (0.33 [0.11-0.96], P = .04). This reduction in postoperative complications translated into a reduced length of stay (mean difference -2.62 [-4.97 to -0.26], P = .03). CONCLUSION: Continuous drain irrigation after pancreatectomy is a novel treatment strategy with a limited body of published evidence. After acknowledging the limitations of the data, initial analysis would suggest that it may serve as an effective risk mitigation strategy against postoperative pancreatic fistula. Further research in a prospective context utilizing patient risk stratification for fistula development is, however, required to define its role within clinical practice.

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.

Efficacy of pancreaticojejunostomy of the pancreatic stump during distal or central pancreatectomy.

BACKGROUND: A stapler is usually used for transection and closure of the pancreas in distal pancreatectomy (DP) or central pancreatectomy (CP). When the pancreas is transected to the right of the portal vein, it is difficult to use a stapler and clinically relevant postoperative pancreatic fistula (CR-POPF) frequently occurs. We report on the efficacy of pancreaticojejunostomy (PJ) of the pancreatic stump for patients in whom stapler use is difficult. METHODS: Patients who underwent DP or CP were enrolled in this study. The pancreas was usually transected by a stapler, and ultrasonic coagulating shears (UCS) were used depending on the tumor situation. When using UCS, hand-sewn closure or PJ was performed for the pancreatic stump. The relationship between clinicopathological factors and the methods of pancreatic transection and closure were investigated. RESULTS: In total, 164 patients underwent DP or CP, and the pancreas was transected with a stapler in 150 patients and UCS in 14 patients. The rate of CR-POPF was higher and the postoperative hospital stay was longer in the UCS group than in the stapler group. PJ of the pancreatic stump, which was performed for 7 patients, did not worsen intraoperative factors. CR-POPF was not seen in these 7 patients, which was significantly less than that with hand-sewn closure. CONCLUSIONS: PJ of the pancreatic stump during DP or CP reduces CR-POPF compared with hand-sewn closure and may be useful especially when the pancreas is transected to the right of the portal vein.

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.

Stent placement for the prevention of clinically-relevant postoperative pancreatic fistula following pancreaticojejunostomy: A systematic review and meta-analysis.

OBJECTIVES: There remains a lack of consensus regarding the benefits of stent placement following pancreaticojejunostomy in terms of clinically relevant postoperative pancreatic fistulas (CR-POPFs). This study was aimed at analyzing the effects of stent placement, stent technique (internal and external), stent size, and dilation of the main pancreatic duct on CR-POPFs. METHODS: Our study comprised a systematic review and meta-analysis of randomized controlled trials involving patients undergoing pancreaticojejunostomy. The primary outcome was defined as the incidence of CR-POPFs. Additionally, subgroup analyses were conducted, and pooled analyses were performed to provide comparative references. RESULTS: Twelve randomized controlled trials, including a total of 1117 patients, were included. Compared with no stent placement, stenting did not exhibit a significant association with reduced CR-POPF incidence (odds ratio [OR] â€‹= â€‹0.60, 95% CI: 0.34-1.04, P â€‹= â€‹0.07). Subgroup analysis revealed that only external stents, and not internal stents, were significantly associated with a reduced CR-POPF incidence compared with no stent placement (OR â€‹= â€‹0.53, 95% CI: 0.28-0.99, P â€‹= â€‹0.05 vs. OR â€‹= â€‹0.92, 95% CI: 0.28-3.05, P â€‹= â€‹0.89). Furthermore, stent placement in patients with a main pancreatic duct diameter of ≤3 â€‹mm, and not in those with a main pancreatic duct diameter of >3 â€‹mm, was associated with a significantly reduced CR-POPF incidence compared with no stent placement (OR â€‹= â€‹0.24, 95% CI: 0.07-0.78, P â€‹= â€‹0.02 vs. OR â€‹= â€‹1.58, 95% CI: 0.41-6.06, P â€‹= â€‹0.50). CONCLUSIONS: The findings suggest a potential role for external stent placement in the prevention of CR-POPFs after pancreaticojejunostomy, particularly in patients with undilated pancreatic ducts. The reliability of our findings is constrained by the limited number of studies included. PROSPERO REGISTRATION NUMBER: CRD42022380103.

Somatostatin Versus Octreotide for Prevention of Postoperative Pancreatic Fistula: The PREFIPS Randomized Clinical Trial: A FRENCH 007-ACHBT Study.

OBJECTIVE: Pharmacological prevention of postoperative pancreatic fistula (POPF) after pancreatectomy is open to debate. The present study compares clinically significant POPF rates in patients randomized between somatostatin versus octreotide as prophylactic treatment. METHODS: Multicentric randomized controlled open study in patient's candidate for pancreaticoduodenectomy (PD) or distal pancreatectomy (DP) comparing somatostatin continuous intravenous infusion for 7 days versus octreotid 100 µg, every 8 hours subcutaneous injection for 7 days, stratified by procedure (PD vs DP) and size of the main pancreatic duct (>4 mm) on grade B/C POPF rates at 90 days based on an intention-to-treat analysis. RESULTS: Of 763 eligible patients, 651 were randomized: 327 in the octreotide arm and 324 in the somatostatin arm, with comparable the stratification criteria - type of surgery and main pancreatic duct dilatation. Most patients had PD (n=480; 73.8%), on soft/normal pancreas (n=367; 63.2%) with a nondilated main pancreatic duct (n=472; 72.5%), most often for pancreatic adenocarcinoma (n=311; 47.8%). Almost all patients had abdominal drainage (n=621; 96.1%) and 121 (19.5%) left the hospital with the drain in place (median length of stay=16 days). A total of 153 patients (23.5%) developed a grade B/C POPF with no difference between both groups: 24.1%: somatostatin arm and 22.9%: octreotide arm (χ 2 test, P =0.73, ITT analysis). Absence of statistically significant difference persisted after adjustment for stratification variables and in per-protocol analysis. CONCLUSION: Continuous intravenous somatostatin is not statistically different from subcutaneous octreotide in the prevention of grade B/C POPF after pancreatectomy. FINDINGS: In the PREFIPS Randomized Clinical Trial including 651 patients, a total of 153 patients (23.5%) developed a grade B/C POPF with no significant difference between both groups: 24.1%: somatostatin arm and 22.9%: octreotide arm (χ 2 test, P =0.73, ITT analysis). Absence of statistically significant difference persisted after adjustment for stratification variables and in per-protocol analysis.

Safety and performance of a synthetic sealant patch aimed to prevent postoperative pancreatic fistula after distal pancreatectomy (SHIELDS) - Prospective international multicenter phase II study.

OBJECTIVE: The incidence for clinically relevant postoperative pancreatic fistulas (CR-POPF) in distal pancreatectomy (DP) ranges up to 25%. None of the available sealants significantly reduce CR-POPF. A new biodegradable sealant patch was able to reduce POPF and to achieve bleeding control in a preclinical porcine DP model. The aim of this first-in-human study was to assess the safety and performance of the sealant patch. METHODS: In this multicenter, single-arm study, 40 patients undergoing distal pancreatectomy were prospectively enrolled from 8 centers. Following surgical resection, the transection plane was closed according to the standard of care and manually covered with the sealant patch. As primary endpoint the incidence of CR-POPF up to 30-days postoperatively was evaluated. The secondary endpoints included the assessment of complications and device usability. RESULTS: Among 40 patients after distal pancreatectomy, CR-POPF occurred in 7 (17.5%) up to postoperative day 30. No type C POPF was observed. There was no intraoperative bleeding observed after patch application. CONCLUSION: The results of this international phase II study demonstrate promising results of a new sealant patch regarding the rate of CR-POPF. Randomized studies are now needed to confirm the superiority of the current patch as compared to the best current practice.

Pancreatic anastomosis training models: Current status and future directions.

Postoperative pancreatic fistula (POPF) is a major cause of morbidity and mortality after pancreatoduodenectomy (PD), and previous research has focused on patient-related risk factors and comparisons between anastomotic techniques. However, it is recognized that surgeon experience is an important factor in POPF outcomes, and that there is a significant learning curve for the pancreatic anastomosis. The aim of this study was to review the current literature on training models for the pancreatic anastomosis, and to explore areas for future research. It is concluded that research is needed to understand the mechanical properties of the human pancreas in an effort to develop a synthetic model that closely mimics its mechanical properties. Virtual reality (VR) is an attractive alternative to synthetic models for surgical training, and further work is needed to develop a VR pancreatic anastomosis training module that provides both high fidelity and haptic feedback.

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).