An interventional study of PrPD with proximal Roux-en-y gastrojejunal anastomosis and conventional PrPD in Pancreatic Cancer, Bile Duct Cancer and Duodenal Cancer, sponsored by The First Affiliated Hospital of Xiamen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-11-03.
Sponsored by The First Affiliated Hospital of Xiamen University · Not applicable, Interventional, and Prevention
This study aims to evaluate whether the incidence of delayed gastric emptying (DGE) can be reduced by proximal Roux-en-y gastrojejunal anastomosis in comparison with the standard gastrojejunal anastomosis in pylorus-resecting pancreaticoduodenectomy (PrPD).
Delayed gastric emptying (DGE) is a common complication after pancreaticoduodenectomy (PD), occurring in 20% to 70% of the patients. DGE is usually not a life-threatening complication, but it contributes significantly to increased length of hospital stay, health care costs, and patient discomfort. In a recent study by Sakamoto et al, proximal Roux-en-y gastrojejunal anastomosis is associated with a reduced incidence of DGE after pylorus-resecting pancreaticoduodenectomy (PrPD); however, these results may have been biased because of the retrospective nature. Therefore, the investigators conducted the present randomized controlled trial (RCT) to evaluate the impact of the proximal Roux-en-y gastrojejunal anastomosis on reducing DGE following PrPD.
217 studies on the registry are indexed under Bile Duct Neoplasms; 43 are open to participants now.
This study's planned enrollment of 140 is above the median of 50 across 161 interventional studies indexed under Bile Duct Neoplasms.
Browse Bile Duct Neoplasms studies →The First Affiliated Hospital of Xiamen University is the lead sponsor of 115 studies on the registry; 76 are open to participants now.
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Exclusion Criteria:
Patients who will undergo PrPD with proximal Roux-en-y gastrojejunal anastomosis.
Procedure: PrPD with proximal Roux-en-y gastrojejunal anastomosis
Patients who will undergo conventional PrPD.
Procedure: conventional PrPD
the distal antrum was divided about 1 to 2 cm proximal to the pylorus ring, preserving more than 95% of the stomach. The proximal jejunum was divided approximately 2 to 4 cm distal to the duodeno-jejunal junction. After completion of the resection, the proximal end of the first loop of jejunum was then brought through the transverse mesocolon, and the gastrojejunal anastomosis (GJA) was performed in two layers by using 3-0 PDS sutures and 4-0 silk sutures in an end-to-side fashion. The jejunum was then divided 35 to 40 cm distal to the GJA, and the distal limb was brought separately through the transverse mesocolon to be placed in the duodenal bed for reconstruction of the pancreatojejunal anastomosis (PJA) and hepatojejunal anastomosis (HJA).
After completion of the pancreatojejunal anastomosis (PJA) and hepatojejunal anastomosis (HJA), a hand-sewn, isoperistaltic GJA was performed 25 to 30 cm distal to the HJA in two layers by using 3-0 polydioxanone (PDS) sutures and 4-0 silk sutures.
Delayed gastric emptying,rate
The severity of DGE was classified into 3 grades (A, B, or C) according to the ISGPS's clinical criteria, based on the patient's clinical course and postoperative management, such as the need for NGT in the postoperative period or the inability to tolerate solid oral intake. Grade A was defined as needing the NGT for more than 7 days or reinsertion of the NGT after postoperative day 3, or as being unable to tolerate a solid diet by postoperative day 7. Grade B was defined as needing for NGT for 8 to 14 days after surgery or reinsertion of the NGT after day 7, or as being unable to tolerate a solid diet by postoperative day 14. Grade C was defined as needing the NGT for more than 14 days or reinsertion of the NGT after day 14, or as being unable to tolerate a solid diet by day 21.
Time frame: 60 days after operation
Morbidity,rate
Time frame: 60 days after operation
Mortality,rate
Time frame: 60 days after operation
Length of hospital stay,days
Time frame: 60 days after operation
Pancreatic fistula,rate
Time frame: 60 days after operation
Hemorrhage,rate
Time frame: 60 days after operation
Bile leakage,rate
Time frame: 60 days after operation
Intra-abdominal abscess,rate
Time frame: 60 days after operation
wound infection,rate
Time frame: 60 days after operation
nonsurgical complications,rate
Time frame: 60 days after operation
Plan to share: No — There is no plan to make individual participant data.
This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital of Xiamen University