Review question
To understand whether stapler or hand-sewn closure is safer and more effective for distal pancreatectomy (removing the tail of the pancreas).
Background
The pancreas is an abdominal organ producing enzymes that aid in digestion and regulation of blood sugar. Cancer of the pancreas is one of the most lethal types of cancer, and the only chance of cure is through radical surgery that removes part of the organ (a surgical procedure known as a resection, and in this case, distal pancreatectomy). Unfortunately, pancreatic surgery is not easy to perform and is complicated by high rates of postoperative complications. One of the most difficult complications is pancreatic fistula, which is when pancreatic enzymes leak from the resection site into the abdominal cavity, reacting with other internal organs to cause pain, infection and bleeding. The best method to prevent such complications is still unknown. Cutting the pancreas with a scalpel and sewing it shut by hand is the oldest method. More recently, surgeons also have had the option of using stapling devices, which cut and close the tissue simultaneously. Today, these two methods are the most commonly used to remove the tail of the pancreas. The aim of this review is to compare which method is safer and more effective.
Study characteristics
We searched several electronic databases to find high quality trials about this topic. Two authors independently read reports on the trials to decide whether or not to include them in the review, and they independently extracted the trial data so as not to miss any important information. The search yielded two high quality trials including a total of 381 participants.
Key results
The statistical analyses resulted in similar rates of pancreatic fistula (about 35%), deaths after surgery (about 1%) and average operation time between the two operation methods.
Individual surgeons can choose which closure technique to use after removing of the tail of the pancreas according to their preferences and the participant's anatomic characteristics.
Quality of the evidence
More high quality trials on this topic would be beneficial, and studies investigating new methods should compare them either to stapler or hand-sewn closure in order to ensure comparability of results.
The quality of evidence is moderate and mainly based on the high weight of the results of one multicentre RCT. Unfortunately, there are no other completed RCTs on this topic except for one relevant ongoing trial. Neither stapler nor scalpel resection followed by hand-sewn closure of the pancreatic remnant for distal pancreatectomy showed any benefit compared to the other method in terms of postoperative pancreatic fistula, overall postoperative mortality or operation time. Currently, the choice of closure is left up to the preference of the individual surgeon and the anatomical characteristics of the patient. Another (non-European) multicentre trial (e.g. with an equality or non-inferiority design) would help to corroborate the findings of this meta-analysis. Future trials assessing novel methods of stump closure should compare them either with stapler or hand-sewn closure as a control group to ensure comparability of results.
Resections of the pancreatic body and tail reaching to the left of the superior mesenteric vein are defined as distal pancreatectomy. Most distal pancreatectomies are elective treatments for chronic pancreatitis, benign or malignant diseases, and they have high morbidity rates of up to 40%. Pancreatic fistula formation is the main source of postoperative morbidity, associated with numerous further complications. Researchers have proposed several surgical resection and closure techniques of the pancreatic remnant in an attempt to reduce these complications. The two most common techniques are scalpel resection followed by hand-sewn closure of the pancreatic remnant and stapler resection and closure.
To compare the rates of pancreatic fistula in people undergoing distal pancreatectomy using scalpel resection followed by hand-sewn closure of the pancreatic remnant versus stapler resection and closure.
We searched Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Biosis and Science Citation Index from database inception to October 2015.
We included randomised controlled trials (RCTs) comparing stapler versus scalpel resection followed by hand-sewn closure of the pancreatic remnant for distal pancreatectomy (irrespective of language or publication status).
Two authors independently assessed trials for inclusion and extracted the data. Taking into consideration the clinical heterogeneity between the trials (e.g. different endpoint definitions), we analysed data using a random-effects model with Review Manager (RevMan), calculating risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CI).
In two eligible trials, a total of 381 participants underwent distal pancreatic resection and were randomised to closure of the pancreatic remnant either with stapler (n = 191) or scalpel resection followed by hand-sewn closure (n = 190). One was a single centre pilot RCT and the other was a multicentre blinded RCT. The single centre pilot RCT evaluated 69 participants in five intervention arms (stapler, hand-sewn, fibrin glue, mesh and pancreaticojejunostomy), although we only assessed the stapler and hand-sewn closure groups (14 and 15 participants, respectively). The multicentre RCT had two interventional arms: stapler (n = 177) and hand-sewn closure (n = 175). The rate of postoperative pancreatic fistula was the main outcome, and it occurred in 79 of 190 participants in the hand-sewn group compared to 65 of 191 participants in the stapler group. Neither the individual trials nor the meta-analysis showed a significant difference between resection techniques (RR 0.90; 95% CI 0.55 to 1.45; P = 0.66). In the same way, postoperative mortality and operation time did not differ significantly. The single centre RCT had an unclear risk of bias in the randomisation, allocation and both blinding domains. However, the much larger multicentre RCT had a low risk of bias in all domains. Due to the small number of events and the wide confidence intervals that cannot exclude clinically important benefit or harm with stapler versus hand-sewn closure, there is a serious possibility of imprecision, making the overall quality of evidence moderate.