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Pylorus preserving pancreaticoduodenectomy has been standard procedure for periampullary benign and malignant disease. Delayed gastric emptying is one of most common complications after the procedure. Recently, pylorus resecting pancreaticoduodenectomy has been actively performed because some studies reported that the procedure can reduce postoperative delayed gastric emptying.
However, the level of evidence is low and there was few studies considering nutritional status after pylorus resecting pancreaticoduodenectomy.
The purpose of this study is to compare between pylorus-resecting and preserving pancreaticoduodenectomy on postoperative delayed gastric emptying and nutritional status.
Full description
Pylorus preserving pancreaticoduodenectomy has been standard procedure for periampullary benign and malignant disease. Delayed gastric emptying is one of most common complications after the procedure. It can lead to delay initiation of adjuvant chemotherapy as well as postoperative recovery. Since 2010, pylorus resecting pancreaticoduodenectomy was introduced to reduce postoperative delayed gastric emptying. The cases have been actively increased. However, several prospective randomized controlled trials reported pylorus resection during pancreaticoduodenectomy did not reduce the incidence or severity of delayed gastric emptying. Recent meta-analysis also showed same results.
Previous randomized controlled trials were single center studies participating a relatively small number of patients. A large-scale multicenter study is needed to obtain high level of evidence. And nutritional difference may appear between pylorus preservation and resection groups. Few studies have dealt with nutritional status between two groups.
This clinical study is a randomized prospective comparative study of the outcome of pylorus resecting and preserving pancreatoduodenectomy, and the research hypothesis is as follows.
The random assignment of this study is assigned according to the order of assignment in the planning stage of the study as a block randomization scheme with appropriate block size set.
Patient management after surgery
preoperative : NRI(weight, albumin), BMI, Blood chemistry, Abdomen&Pelvic Computed Tomography(APCT) (body composition calculation)
1day after surgery : blood chemistry, removal of nasogastric tube, water intake, early gate
2days after surgery : start diet (liquid or solid)
3days after surgery : blood chemistry, intravenous patient controlled analgesia removal, after 3 days, considering drain amylase and drain volume it can be removed.
5days after surgery : APCT
7days after surgery : NRI(weight, albumin), blood chemistry, tumor marker(if pathology is malignant)
14days after surgery : NRI(weight, albumin), blood chemistry
21days after surgery : NRI(weight, albumin), blood chemistry
3months after surgery : NRI(weight, albumin), blood chemistry, APCT (body composition check)
6months after surgery : NRI(weight, albumin), blood chemistry, APCT (body composition check)
12months after surgery : NRI(weight, albumin), blood chemistry, APCT(body composition check)
** Daily check amount of food intake from operation to discharge(Grade 1~3)
Grade I: 30% or less of the provided amount can be consumed
Grade II: 30~50% of the provided amount can be consumed
Grade III: 50% or more of the provided amount can be consumed
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394 participants in 2 patient groups
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Bong Jun Kwak, MD
Data sourced from clinicaltrials.gov
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