Markus K. Diener

Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial

BACKGROUND The ideal closure technique of the pancreas after distal pancreatectomy is unknown. We postulated that standardised closure with a stapler device would prevent pancreatic fistula more effectively than would a hand-sewn closure of the remnant. METHODS This multicentre, randomised, controlled, parallel group-sequential superiority trial was done in 21 European hospitals. Patients with diseases of the pancreatic body and tail undergoing distal pancreatectomy were eligible and were randomly assigned by central randomisation before operation to either stapler or hand-sewn closure of the pancreatic remnant. Surgical performance was assessed with intraoperative photo documentation. The primary endpoint was the combination of pancreatic fistula and death until postoperative day 7. Patients and outcome assessors were masked to group assignment. Interim and final analysis were by intention to treat in all patients in whom a left resection was done. This trial is registered, ISRCTN18452029. FINDINGS Between Nov 16, 2006, and July 3, 2009, 450 patients were randomly assigned to treatment groups (221 stapler; 229 hand-sewn closure), of whom 352 patients (177 stapler, 175 hand-sewn closure) were analysed. Pancreatic fistula rate or mortality did not differ between stapler (56 [32%] of 177) and hand-sewn closure (49 [28%] of 175; OR 0·84, 95% CI 0·53–1·33; p=0·56). One patient died within the fi rst 7 days after surgery in the hand-sewn group; no deaths occurred in the stapler group. Serious adverse events did not differ between groups. INTERPRETATION Stapler closure did not reduce the rate of pancreatic fistula compared with hand-sewn closure for distal pancreatectomy. New strategies, including innovative surgical techniques, need to be identified to reduce this adverse outcome. FUNDING German Federal Ministry of Education and Research.

Distal pancreatectomy: risk factors for surgical failure in 302 consecutive cases.

Objective:The objective of this study was to identify potential risk factors for mortality and morbidity after distal pancreatectomy, with special focus on the formation of pancreatic fistula. Summary Background Data:Distal pancreatectomy can be performed with low mortality and acceptable morbidity rates. Pancreatic fistulas, occurring in 10% to 20% of cases, remain a problem that contributes significantly to morbidity, length of stay, and overall costs. Methods:From November 1993 to February 2006, perioperative and postoperative data of 302 consecutive patients were recorded. Univariate and multivariate analyses of potential risk factors for morbidity and for the formation of pancreatic fistula were performed. The surgical techniques used for closure were categorized into 4 groups: 1) anastomosis, 2) seromuscular patch, 3) closure by suture, and 4) closure using a stapling device. Results:Indications for resection were pancreatic tumors in 62% of patients, nonpancreatic tumors in 23%, chronic pancreatitis in 12%, and others in 3%. The spleen was preserved in 24% of patients. The morbidity and mortality rates for distal pancreatectomy in this series were 35% and 2%, respectively. The prevalence of pancreatic fistula was 12%. Univariate and multivariate analyses indicated that closure using a stapling device and an operating time ≥480 minutes were associated with a higher incidence of pancreatic fistula (odds ratio = 2.6 and 4.2, respectively). Overall morbidity was mainly influenced by the extent of resection (multivisceral vs. conventional; odds ratio = 1.7). Conclusion:Pancreatic leak remains a common complication after distal pancreatectomy. Our series suggests that stapler closure of the pancreatic remnant is associated with a significantly higher fistula rate.

Systematic review and meta-analysis of technique for closure of the pancreatic remnant after distal pancreatectomy

Appropriate closure of the pancreatic remnant after distal pancreatectomy is still debated. A variety of procedures have been recommended to reduce the frequency of pancreatic fistula. This review quantitatively compares the available techniques.

Systematic review and meta‐analysis of standard and extended lymphadenectomy in pancreaticoduodenectomy for pancreatic cancer

Although some retrospective studies of extended radical lymphadenectomy for pancreatic cancer have suggested a survival advantage, this is controversial.

A systematic review and meta-analysis of pylorus-preserving versus classical pancreaticoduodenectomy for surgical treatment of periampullary and pancreatic carcinoma.

Objective:Comparison of effectiveness between the pylorus-preserving pancreaticoduodenectomy (“pylorus-preserving Whipple” [PPW]) and the classic Whipple (CW) procedure. Methods:A systematic literature search (Medline, Embase, Cochrane Library, Biosis, Science Citation Index, Ovid Journals) was performed to identify all eligible articles. Randomized controlled trials (RCTs) comparing PPW versus CW for periampullary and pancreatic carcinoma were eligible for inclusion. The methodologic quality of included studies was evaluated independently by 2 authors. Quantitative data on perioperative parameters (blood loss, transfusion, operation time, and length of hospital stay), mortality, morbidity, and survival were extracted from included studies for meta-analysis. Pooled estimates of overall treatment effect were calculated using a random effects model. Results:In total, 1235 abstracts were retrieved and checked for eligibility and 6 RCTs finally included. The critical appraisal revealed vast heterogeneity with respect to methodologic quality and outcome parameters. The comparison of overall in-hospital mortality (odds ratio, 0.49; 95% CI, 0.17 to 1.40; P = 0.18), morbidity (odds ratio 0.89; 95% CI, 0.48 to 1.62; P = 0.69), and survival (hazard ratio, 0.74; 95% CI, 0.52 to 1.07; P = 0.11) showed no significant difference. However, operating time (weighted mean difference, −68.26 minutes; 95% CI, −105.70 to −30.83; P = 0.0004), and intraoperative blood loss (weighted mean difference, −766 mL; 95% CI, −965.26 to −566.74; P = 0.00001) were significantly reduced in the PPW group. Conclusion:Hence, in the absence of relevant differences in mortality, morbidity, and survival, the PPW seems to be as effective as the CW. Given obvious clinical and methodological interstudy heterogeneity, efforts should be intensified in the future to perform high quality RCTs of complex surgical interventions on the basis of well defined outcome parameters.

Meta-analysis Shows That Detection of Circulating Tumor Cells Indicates Poor Prognosis in Patients With Colorectal Cancer

BACKGROUND & AIMS The prognostic significance of circulating (CTCs) and disseminated tumor cells in patients with colorectal cancer (CRC) is controversial. We performed a meta-analysis of available studies to assess whether the detection of tumor cells in the blood and bone marrow (BM) of patients diagnosed with primary CRC can be used as a prognostic factor. METHODS We searched the Medline, Biosis, Science Citation Index, and Embase databases and reference lists of relevant articles (including review articles) for studies that assessed the prognostic relevance of tumor cell detection in the peripheral blood (PB), mesenteric/portal blood (MPB), or BM of patients with CRC. Meta-analyses were performed using a random effects model, with hazard ratio (HR) and 95% confidence intervals (95% CIs) as effect measures. RESULTS A total of 36 studies, including 3094 patients, were eligible for final analyses. Pooled analyses that combined all sampling sites (PB, MPB, and BM) associated the detection of tumor cells with poor recurrence-free survival (RFS) (HR = 3.24 [95% CI: 2.06-5.10], n = 26, I(2) = 77%) and overall survival (OS) (2.28 [1.55-3.38], n = 21, I(2) = 66%). Stratification by sampling site showed that detection of tumor cells in the PB compartment was a statistically significant prognostic factor (RFS: 3.06 [1.74-5.38], n = 19, I(2) = 78%; OS: 2.70 [1.74-4.20], n = 16, I(2) = 59%) but not in the MPB (RFS: 4.12 [1.01-16.83], n = 8, I(2) = 75%; OS: 4.80 [0.81-28.32], n = 5, I(2) = 82%) or in the BM (RFS: 2.17 [0.94-5.03], n = 4, I(2) = 78%; OS: 1.50 [0.52-4.32], n = 3, I(2) = 84%). CONCLUSION Detection of CTCs in the PB indicates poor prognosis in patients with primary CRC.

Interrupted or continuous slowly absorbable sutures for closure of primary elective midline abdominal incisions: a multicenter randomized trial (INSECT: ISRCTN24023541).

Objective:In patients undergoing midline incisions, the abdominal fascia can be closed with a continuous or interrupted suture using various materials. The aim of this study is to compare: (1) interrupted technique with rapidly absorbable sutures and (2) continuous techniques with different slowly absorbable sutures, focusing on the incidence of incisional hernias within 1 year. Summary of Background Data:A meta-analysis suggested that the incidence of incisional hernias can be more effectively reduced with slowly absorbable continuous sutures. Methods:Multicenter randomized surgical trial with 3 parallel groups. Patients were scheduled for primary elective midline incisions. All surgeons were trained (4:1 suture wound length in continuous groups) and monitored. Primary end point, measured within 1 year after surgery, was the frequency of incisional hernias diagnosed by clinical examination and confirmed by ultrasound. Complications and safety were used as secondary end points. This study has been registered with the ISRCTN Register (INSECT: ISRCTN24023541). Results:Conducted on 625 randomized patients (210 interrupted Vicryl, 205 continuous polydioxanone suture (PDS), 210 continuous Monoplus), the primary analysis showed an incidence of 28 incisional hernias (15.9%) versus 15 (8.4%) versus 22 (12.5%) for the 3 closure techniques, respectively (P = 0.09). No significant difference was observed between the 3 groups with regard to burst abdomen (4 [2.0%] vs. 6 [3.0%] vs. 8 [4.0%], P = 0.46), wound infection (26 [12.7%] vs. 39 [19.4%] vs. 33 [16.3%], P = 0.19), pulmonary infections (9 [4.4%] vs. 5 [2.5%] vs. 5 [2.5%], P = 0.46), serious adverse events (63 [30.0%] vs. 57 [27.8%] vs. 61 [29.1%], P = 0.89), and 1-year mortality (16 [7.9%] vs. 11 [5.5%] vs. 16 [7.9%], P = 0.54). Conclusions:The incidence of incisional hernias and the frequency of wound infection was higher than expected in all groups. New concepts need to be developed and studied to substantially reduce the frequency of incisional hernias.

Elective midline laparotomy closure: the INLINE systematic review and meta-analysis.

Objective:To evaluate the optimal technique and material for abdominal fascia closure after midline laparotomy, first by means of a precisely defined study population and follow-up period and second by the surgically driven aspects. Methods:Overview of existing systematic reviews and meta-analysis of randomized controlled trials. A systematic literature search (Medline, Embase, and The Cochrane Central Register of Controlled Trials) was performed to identify randomized controlled trials in elective and emergency populations comparing suture techniques (continuous vs. interrupted) and materials (rapidly vs. slowly vs. nonabsorbable). Random effects conventional and cumulative meta-analyses were calculated and presented as odds ratios and the corresponding 95% confidence intervals. Results:Five systematic reviews and 14 trials including 7711 patients (6752 midline incisions) were analyzed. None of the systematic reviews differentiated elective versus emergency laparotomy. The analysis of available primary studies revealed significant lower hernia rates using a continuous (vs. interrupted) technique (OR: 0.59; P = 0.001) with slowly absorbable (vs. rapid-absorbable) suture material (OR: 0.65; P = 0.009) in the elective setting, which was in contrast to the conflicting results of existing systematic reviews. No statistical heterogeneity was detected in the elective setting (I2 = 0%). Seven studies incorporating elective and emergency procedures revealed inconclusive and heterogeneous results (I2 = 45%–85%). No studies have evaluated closure methods solely in the emergency setting so far. Conclusion:No further trials should be conducted for evaluation of technique and available materials for elective midline abdominal fascial closure, according to the results of our cumulative meta-analysis. Future trials will have to define the optimal closure strategy in the emergency setting and relevance of new suture materials and other strategies such as the use of prophylactic mesh in targeted subpopulations.

Preoperative tissue diagnosis for tumours of the pancreas

Preoperative biopsy of pancreatic lesions suspected of malignancy is controversial.

IDEAL framework for surgical innovation 1: the idea and development stages.

IDEAL is a framework for evaluations of surgical innovations, which follow a distinct development pathway differing from the approach developed for pharmacological interventions. Many pathway and evaluation challenges are shared by other interventional therapies, requiring individual therapist skills and customisation of treatment to the individual, partly through medical devices. This paper provides an overview of the IDEAL framework and recommendations, and focuses on the first two stages: idea and development.