Intraoperative biodegradable stent placement to reduce complications after pancreatoduodenectomy - Interim results from a randomised clinical trial.

Is it time to standardize patient factors for HPB surgery?

Objective To study the use of a preoperative predictive scoring system established by the Beth Israel Deaconess Medical Center, Washington University School of Medicine and Hospital of the University of Pennsylvania for patients with clinically relevant postoperative pancreatic fistula (CR-POPF) after pancreaticoduodenectomy. Methods The clinical data of 394 patients who underwent pancreaticoduodenectomy at the Provincial Hospital Affiliated to Anhui Medical University from September 2007 to December 2015 were retrospectively analyzed. The four indexes including the gland texture, pathology, pancreatic duct diameter and intraoperative blood loss were calculated for the predictive score system using the logistic regression test. The factors associated with CR-POPF were analyzed. The sensitivity and specificity of the predictive scoring system were determined by the receiver operating characteristic (ROC) curve analysis. Results Of the 70 patients who were diagnosed to have postoperative pancreatic fistula (POPF), 34 were CR-POPF, which included 36 with grade A, 23 with grade B and 11 with grade C. Univariate analysis showed that male, preoperative serum total bilirubin level ≥170 mmol/L, pancreatitis or pancreatic cancer, portal vein invasion, soft pancreatic texture, main pancreatic duct diameter ≤3 mm, and pancreaticojejunostomy were significantly related to POPF after pancreaticoduodenectomy (P<0.05). Portal vein invasion, pancreatic texture and main pancreatic duct diameter were the risk factors of CR-POPF after pancreaticoduodenectomy (P<0.05). Multivariate analysis showed the independent risk factors associated with POPF were male, preoperative serum total bilirubin level ≥170 mmol/L, soft pancreatic texture and main pancreatic duct diameter ≤3 mm (P<0.05), while soft pancreatic texture and main pancreatic duct diameter ≤3 mm were the independent risk factors of CR-POPF (P<0.05). There were significant differences in the clinical relevant postoperative pancreatic fistula rates among the negligible risk, low risk, intermediate risk, and high risk patients with CR-POPF (P<0.05). The results of ROC curve analysis showed that the sensitivity and specificity of the Fistula Risk Scoring system were 76.5% and 95.8%, respectively. The nomogram showed the area under the curve was 0.913 (95%CI: 0.858~0.968). Conclusion The preoperative predictive scoring system accurately predicted the occurrence of CR-POPF. Key words: Pancreatic fistula risk score; Pancreaticoduodenectomy; Pancreatic fistula; Prediction

Predictors of prolonged pancreatic fistula in patients undergoing pancreatoduodenectomy (whipple procedure)

Background: Pancreaticojejunostomy (PJ) is the ''Achilles heel” of pancreaticoduodenectomy (PD) which affects perioperative as well as oncological outcomes. However, there is a lack of information about the superiority of the type of anastomosis in terms of overall morbidity and postoperative pancreatic fistula (POPF) after PD. Here, we compare the outcomes of modified Blumgart PJ with the dunking technique of PJ.Methodology: A case-control study of a prospectively maintained database of 25 consecutive patients undergoing modified Blumgart PJ (study group) and 25 patients who underwent continuous dunking PJ (control group) between January 2018 to April 2021 was done. Between groups, comparisons were made for the duration of surgery, intraoperative blood loss, original fistula risk score, overall complications as graded by Clavien Dindo (CD), POPF, post pancreatectomy haemorrhage (PPH), delayed gastric emptying (DGE), and 30-day mortality at 95% confidence level.Results: Among 50 patients, 30 (60%) were male. The most common indication for PD was ampullary carcinoma (44% in the study group vs. 60% in the control group). The duration of surgery was approximately 41 minutes longer in the study group compared to the control (p = 0.02), while the intraoperative blood loss was similar between the two groups (496.00 ± 226.35 ml vs 508.00 ± 180.67 ml, p = 0.84). While there was no significant difference in mean fistula risk score between the two groups, the POPF (8% vs 32%, p = 0.03), PPH (0% vs 20%, p =0.02), and overall major complications (CD≥ III) according to CD Grading (12% vs 40%, p = 0.02) were significantly lower in the study group. Similarly, the duration of hospital stay in the study group was 4.64 days shorter than the control group (p = 0.001). However, there was no significant difference in the 30-day mortality between the two groups.Conclusions: Modified Blumgart pancreaticojejunostomy has better perioperative outcomes in terms of procedure-specific complications like POPF, PPH, overall major postoperative complications, and duration of hospital stay.

Pancreaticojejunostomy With Externalized Stent vs Pancreaticogastrostomy With Externalized Stent for Patients With High-Risk Pancreatic Anastomosis A Single-Center, Phase 3, Randomized Clinical Trial

Comparison of Postoperative Pancreatic Fistula Rates of Laparoscopic Versus Robotic Pancreaticojejunostomy after Pancreaticoduodenectomy in Soft Pancreas with Small Pancreatic Duct; a Multi-Center Study with a Propensity Score Matching Analysis

A retrospective study comparing external and internal without stent pancreatic drainage after pancreatic operation

This study aimed to investigate the clinical significance and risk factors of postoperative pancreatic fistula (POPF) after post-pancreatectomy acute pancreatitis (PPAP) in patients who underwent pancreaticoduodenectomy (PD). PPAP has been recognized as a critical factor in the pathophysiology of POPF after PD. A total of 817 consecutive patients who underwent elective PD between January 2020 and June 2022 were included. PPAP and POPF were defined in accordance with the International Study Group for Pancreatic Surgery (ISGPS) definitions. Multivariate logistic analyses were performed to investigate the risk factors for POPF. Comparisons between PPAP-associated POPF and non-PPAP-associated POPF were made to further characterize this intriguing complication. Overall, 159 (19.5%) patients developed POPF after PD, of which 73 (45.9%) occurred following PPAP, and the remaining 86 (54.1%) had non-PPAP-associated POPF. Patients with PPAP-associated POPF experienced significantly higher morbidity than patients without POPF. Multivariate analyses revealed distinct risk factors for each POPF type. For PPAP-associated POPF, independent risk factors included estimated blood loss >200mL (OR: 1.93), main pancreatic duct ≤3cm (OR: 2.88), and soft pancreatic texture (OR: 2.01), largely overlapping with fistula risk score elements. On the other hand, non-PPAP-associated POPF was associated with age >65 years (OR: 1.95), male (OR: 2.10), and main pancreatic duct ≤3cm (OR: 2.57). Notably, among patients with PPAP, the incidence of POPF consistently hovered around 50% regardless of the fistula risk score stratification. PPAP-associated POPF presents as a distinct pathophysiology in the development of POPF after PD, potentially opening doors for future prevention strategies targeting the early postoperative period.

Introduction Chen’s U-suture technique has undergone revisions since it was first devised and has shown low postoperative pancreatic fistula (POPF) rates after pancreaticoduodenectomy (PD). This study aims to evaluate the efficacy of the modified Chen’s U-suture technique among patients with soft pancreas and small pancreatic duct (diameter ≤3mm), either with or without stent placement. Methods Of 1852 patients screened, 198 patients with high-risk anatomy who received the modified Chen’s U-suture technique for PD from 6 hospitals between 2018 and 2024 were included. Patients were classified into the stent (n = 159) and the non-stent group (n = 39) according to whether a pancreatic duct stent was placed. The primary endpoint was to evaluate the rate of POPF. Results Among the patients, four (2.5%) experienced grade B POPF, without grade C POPF occurred. A higher biochemical leak rate was observed in the non-stent group (n = 16, 41.0%) than in the stent group (n = 14, 8.8%) (p < 0.001). No statistically significant difference was found between the two groups in overall complication rates (30.8% vs. 37.7%, p = 0.407). Discussion This technique is reliable for patients with soft pancreas and small pancreatic duct, including those who have ducts too small to undergo stent placement.

To evaluate the efficacy of transanastomotic pancreatic duct internal stenting in the reduction of postoperative pancreatic fistula (POPF) after pancreaticoduodenectomy. Retrospective study. Mayo Clinic. Between January 1, 1999, and September 30, 2010, 553 patients underwent pancreaticoduodenectomy by a single surgeon. Rates of POPF, morbidity, and mortality between stent and no-stent groups. The clinically relevant POPF (International Study Group on Pancreatic Fistula definition grade B or C) rates in the stent and no-stent groups were similar (9.6% [43 of 449 patients] and 12.5% [13 of 104 patients], respectively; P=.38). Postoperative outcomes and morbidity were also similar between the 2 groups. Mortality was 0.7% (3 of 449 patients) for the stent group and 1.0% (1 of 104 patients) for the no-stent group. Four patients (0.9%) required endoscopic retrieval of the anastomotic stent. In subset analysis, the clinically relevant POPF rates in patients with a small pancreatic duct (≤3 mm; n=167) were similar in the stent and no-stent groups (17.7% [23 of 130 patients] and 24.3% [9 of 37 patients], respectively; P=.38). In patients with a soft pancreatic gland (n=64), rates of clinically relevant pancreatic fistulae were also similar in the stent and no-stent groups (31.7% [13 of 41 patients] and 17.4% [4 of 23 patients], respectively; P=.20). Internal transanastomotic pancreatic duct stenting does not decrease the frequency or severity of POPF. The effect of stenting on long-term anastomotic patency warrants further investigation.

Soft pancreas with small pancreatic duct is a known risk factor for postoperative pancreatic fistula (POPF). This study demonstrated the safety and feasibility of laparoscopic duct-to-mucosa pancreaticojejunostomy (PJ) and compared perioperative outcomes of laparoscopic pancreaticoduodenectomy (LPD) and open pancreaticoduodenectomy (OPD) in patients with soft pancreas and small pancreatic duct. From January 2014 to December 2019, 183 patients underwent LPD and 91 patients underwent OPD by a single surgeon. Data on patients with soft pancreas and combined small pancreatic duct (≤ 2mm) were retrospectively reviewed. Clinicopathologic characteristics, and perioperative outcomes were compared between LPD and OPD. We evaluated risk factors affecting clinically relevant POPF (CR-POPF). We also correlated calculated risks of POPF and CR-POPF between the two groups. We compared 62 patients in the LPD group and 34 patients in the OPD group. Perioperative outcomes showed less blood loss, shorter hospital stays, and less postoperative pain score on postoperative day (POD)#1 and #5 in LPD compared with OPD. Postoperative complications showed no differences between LPD and OPD. LPD group showed significantly reduced CR-POPF rates compared to the OPD group (LPD 11.3% vs. OPD 29.4%, p = 0.026). Multivariate analysis identified obesity (BMI ≥ 25), thick pancreas parenchyma and open surgery as independent predicting factors for CR-POPF. The LPD group showed less CR-POPF than the OPD group according to POPF risk groups. This difference was more prominent in a high-risk group. With appropriate laparoscopic technique, LPD is feasible and safe and reduces CR-POPF in soft pancreas with a small pancreatic duct.

The operative scenarios with the highest postoperative pancreatic fistula (POPF) risk represent situations in which fistula prevention and mitigation strategies have the strongest potential to affect surgical outcomes after pancreaticoduodenectomy. Evidence from studies providing risk stratification is lacking. To investigate whether pancreaticojejunostomy (PJ) or pancreaticogastrostomy (PG), both with externalized transanastomotic stent, is the best reconstruction method for patients at high risk of POPF after pancreaticoduodenectomy. A single-center, phase 3, randomized clinical trial was conducted at the Department of General and Pancreatic Surgery, The Pancreas Institute, University of Verona Hospital Trust, Verona, Italy, from July 12, 2017, through March 15, 2019, among adults undergoing elective pancreaticoduodenectomy and considered at high risk for pancreatic fistula after intraoperative assessment of the fistula risk score, some of whom were randomized to undergo PG or PJ. All analyses were performed on an intention-to-treat basis. Intervention consisted of PJ or PG, both with externalized transanastomotic stent and octreotide omission. The primary end point was POPF. The secondary end points were Clavien-Dindo grade 3 or higher morbidity, postpancreatectomy hemorrhage, delayed gastric emptying, and average complication burden. A total of 604 patients were screened for eligibility; 82 were at high risk for POPF (fistula risk score, 7-10), and 72 were randomized undergo PG (n = 36; 20 men and 16 women; median age, 65 years [interquartile range, 23-82]) or PJ (n = 36; 26 men and 10 women; median age, 63 years [interquartile range, 35-79]). There was no significant difference in the incidence of POPF between patients who underwent PG and patients who underwent PJ (18 [50.0%] vs 14 [38.9%]; P = .48), but for patients who developed a POPF, the mean (SD) average complication burden was lower for those who underwent PJ than for those who underwent PG (0.25 [0.13] vs 0.39 [0.17]; P = .04). The rates of postpancreatectomy hemorrhage (14 [38.9%] in the PG group vs 9 [25.0%] in the PJ group; P = .31) and delayed gastric emptying (16 [44.4%] in the PG group vs 18 [50.0%] in the PJ group; P = .81) were similar, but patients who underwent PG presented with a significantly higher incidence of Clavien-Dindo grade 3 or higher morbidity than those who underwent PJ (17 [47.2%] vs 8 [22.2%]; P = .047). Among patients at the highest risk for POPF, those who underwent PG or PJ experienced similar rates of POPF. However, PG was associated with an increased incidence of Clavien-Dindo grade 3 or higher morbidity and with an increased average complication burden for the patients who developed a POPF. For patients at high risk for pancreatic fistula, PJ with the use of externalized stent and octreotide omission should be considered the most appropriate technical strategy. ClinicalTrials.gov Identifier: NCT03212196.

A Single-Center, Phase 3, Randomized Controlled Trial of Pancreaticojejunostomy vs Pancreaticogastrostomy with Externalized Stent in High-Risk Pancreatic Anastomosis

BackgroundThe pancreatic reconstruction technique decides the incidence of postoperative pancreatic fistulas (POPF) in pancreaticoduodenectomy (PD). This study aims to evaluate the safety of modified single-needle continuous suture (SNCS) of duct-to-mucosa and compare the efficacy with double-layer continuous suture (DLCS) of duct-mucosa pancreaticojejunostomy (PJ) in open PD (OPD).MethodsA total of 266 patients that received PD between January 2019 and May 2023 were retrospectively analyzed. Among them, 130 patients underwent DLCS, and 136 patients underwent SNCS [73 OPD and 63 laparoscopic PD (LPD)]. The primary outcome was clinically relevant POPF (CR-POPF) according to the definition of the revised 2016 International Study Group of Pancreatic Fistula (ISGPF). Propensity score matching (PSM) was conducted to reduce confounding bias.ResultsA total of 66 pairs were successfully matched using PSM in OPD. No significant difference was observed in the occurrence of CR-POPF between the two groups (9.1% vs. 21.2%, P=0.052). However, the median duration of operation and PJ was shorter in the SNCS group. The incidence of CR-POPF in LPD was 9.5%. Furthermore, regarding the alternative fistula risk score (a-FRS), the CR-POPF rate were 2.1%, 10.5%, and 15.6% in low-, intermediate-, and high-risk groups (P=0.067).ConclusionsThe SNCS is a facile, safe, and effective PJ technique and does not increase the incidence of POPF, regardless of a-FRS stratification, pancreatic texture, and main pancreatic duct (MPD) size.

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