Is Nasogastric Tube Necessary After Pancreaticoduodenectomy?
Is Nasogastric Tube Necessary After Pancreaticoduodenectomy?
Nasogastric decompression was routinely used in most major intra-abdominal operations.
 Nasogastric tube intubation was thought to decrease postoperative ileus (nausea, vomiting,
 and gastric distension). Would and respiratory complications, and to reduce the incidence of
 anastomotic leaks after gastrointestinal surgery. However, the necessity of nasogastric
 decompression following elective abdominal surgery has been increasingly questioned over the
 last several years. Many clinical studies have suggested that this practice does not provide
 any benefit but could increase patient discomfort and respiratory complications. Furthermore,
 meta-analyses have concluded that routine nasogastric decompression is no longer warranted
 after elective abdominal surgery.

 Elective abdominal surgery without nasogastric decompression was initially tested and then
 widely used on patients with colorectal surgery.However, after upper gastrointestinal
 operations such as gastrectomy, nasogastric has been considered necessary to prevent the
 consequences of postoperative ileus (anastomotic leakage or leaking from the duodenal stump.
 Therefore, studies of gastrectomy without nasogastric tube emerged later than those of
 colectomy. In spite more and more studies reported of no need of nasogastric tube after
 abdominal operation, no papers reported after pancreaticoduodenectomy. Postulated causes of
 lack in studies to assess the need of a nasogastric tube after pancreaticoduodenectomy
 include anticipated prolonged postoperative paralytic ileus caused by PD-related extensive
 destruction and potential risk of gastric stasis after PD. However, our pilot study of
 retrospective analysis of postoperative NG drainage amount in 100 patients recently having PD
 at our hospital showed more than 90% of patients had less than 200cc/day NG drainage amount
 within postoperative day three. Theoretically, these patients might not need a nasogastric
 tube after pancreaticoduodenectomy. Therefore, investigators propose a prospective
 multicenter randomized trial to assess the need of a nasogastric tube after PD.
The study will be started only after approval of Ethics Committee of National Taiwan
 University Hospital and consent sheet will be obtained from all included patients.

 Patients planned to have PD at national Taiwan University Hospital will be included in this
 study after obtaining their consent sheet. Patients with emergency surgery, history of upper
 abdominal operation, or other underlying symptoms causing vomiting would be excluded from the
 study. PD will be performed as described before, including feeding gastrostomy tube. The type
 of surgery (pylorus preserving or standard PD) and the type of management of the pancreatic
 stump (duct-to-mucosa pancreaticojejunostomy, serosal pancreaticojejunostomy, or
 pancreaticogastrostomy) will be left to the surgeons' discretion.

 Included patients will be randomized into postoperatively maintaining tube group and non-tube
 control group. Patients in the maintaining tube group will have a 14- or 16-French
 nasogastric tube inserted before the operation. For patients in both maintaining tube and
 non-tube groups, enteral feeding will be routinely went on within 24 h after the operation
 and consisted from 480 mL (20 mL/h continuously) of commercially available enteral nutrition
 solution, with a calorie-to-milliliter ratio of 1:1 and glucose-to-lipid ratio of 70:30. The
 rate of delivery will be progressively increased by 10 mL/day until the goal of full
 nutrition (25~30 kcal/kg) will be reached. Enteral nutrition will be reduced and subsequently
 stopped when the patient is able to eat a sufficient amount of food without vomiting. In some
 patients, feeding rates will be reduced or stopped as a result of significant abdominal
 symptoms after advancement to full enteral support via the jejunostomy tube in the first few
 postoperative days. At that time, many were beginning oral diets and therefore jejunostomy
 feeding was not increased or even withdrawn. Patients who could not resume oral intake will
 be encouraged daily to maintain or increase enteral feeding to the level of the nutrition
 goal.

 For patients in non-tube group, the tube was removed right after suction off gastric fluid
 after extubation weather in operative theater or surgical intensive care unit. After first
 flatus passage, the patient will be allowed to drink 300-500 mL of liquids, and afterwards a
 soft diet will be given for 2 days. If this well tolerated, increasing amounts of solid food
 will be given. The tube will be reinserted if the patient later vomits a volume of more than
 300 mL on more than one occasion. Reinserted tubes will be removed if the reflux is less than
 200 mL per 24 h, and oral feeding (initially with a liquid diet) will be tried again.

 For patients in maintaining tube group, the nasogastric tube will be maintained even the
 endotracheal tube is removed. After first flatus passage, the patient will be allowed to
 drink 300-500 mL of liquids, and afterwards a soft diet will be given for 2 days. The tube
 will be clumped if the drainage amount less than 200mL within 24 hours then be removed 1-2
 days later if there is no vomitus after tube clumping. If this well tolerated, increasing
 amounts of solid food will be given. The tube will be reinserted after removal if the patient
 later vomits a volume of more than 300 mL on more than one occasion. Reinserted tubes will be
 removed if the reflux is less than 200 mL per 24 h, and oral feeding (initially with a liquid
 diet) will be tried again.

 Members of the surgical staff, not involved in the trial, will record postoperative
 complications. The postoperative course of each patient will be closely monitored. The day of
 passage of flatus and oral food intake, the duration of nasogastric tube or nasojejunal
 decompression, and length of hospital stay will be recorded. Mortality, abdominal
 complications, pulmonary complications (pneumonia, atelectasis), postoperative fever, nausea,
 and vomiting, tube insertion or reinsertion, and discomfort from the tube (ear pain, nasal
 soreness, painful swallowing) will be noted. According to the recommendation by the
 International Study Group of Pancreatic Surgery (ISGPS), gastroparesis will be defined as the
 need for an NGT for >3 days or the need to reinsert the NGT for persistent vomiting after
 surgery. The severity of gastroparesis will be classified by the ISGPS definition as grade A:
 NGT required for 4-7 days or reinsertion after postoperative day (POD) 3 or inability to
 tolerate solid oral intake by POD 7; grade B: NGT required for 8-14 days or inability to
 tolerate solid oral intake by POD 14; grade C: NGT required for >14 days or inability to
 tolerate solid food by POD 21. Again, according to the International Study Group definition,
 postoperative pancreatic fistula will be defined as output via an operatively placed drain
 (or a subsequently placed percutaneous drain) of any measurable volume of drain fluid on or
 after POD 3, with an amylase content greater than three times the upper normal serum value.
 Postoperative bleeding will also be graded using ISGPS definitions. All infectious
 complications will be proven by microbiological analysis and positive fluid.

 To compare the control and modified groups, all surgical complications will be further
 classified by severity using a novel grading system proposed by Dindo et al. In brief, grade
 I and II complications include only minor deteriorations from the normal postoperative course
 that can be treated with drugs, blood transfusion, physiotherapy, and nutritional supply.
 Grade III complications require interventional treatment. Grade IV complications are
 life-threatening and require intensive care unit management. Death is the only grade V
 complication. Grade I and II complications will be classified as minor and grades III, IV,
 and V will be classified as major.

 The primary objective for comparison will be the difference in postoperative course
 determined by continuous variables (time to first passage of flatus, first oral intake,
 duration of postoperative perfusions, and hospital stay after operation).
Inclusion Criteria:

 -  Patients receiving pancreaticoduodenectomy

 Exclusion Criteria:

 -  Peritonitis history

 -  Present obstruction evidence or symptoms

 -  Previous abdominal operation

 -  Pregnancy

 -  Gastroesophageal reflux disease

 -  Disease causing vomitus prior to operation