Clinical Trial: Proximal Roux-en-y Gastrojejunal Anastomosis on Delayed Gastric Emptying After Pylorus-resecting Pancreaticoduodenectomy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Proximal Roux-en-y Gastrojejunal Anastomosis on Delayed Gastric Emptying After Pylorus-resecting Pancreaticoduodenectomy: A Randomized Controlled Trial

Brief Summary: 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).

Detailed Summary: 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.
Sponsor: The First Affiliated Hospital of Xiamen University

Current Primary Outcome: Delayed gastric emptying,rate [ Time Frame: 60 days after operation ]

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.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: The First Affiliated Hospital of Xiamen University

Dates:
Date Received: September 7, 2016
Date Started: September 2016
Date Completion: December 2018
Last Updated: November 1, 2016
Last Verified: November 2016