Clinical trial NCT02954302: Proximal Roux-en-y Gastrojejunal Anastomosis on Delayed Gastric Emptying After Pylorus-resecting Pancreaticoduodenectomy
Official title: Proximal Roux-en-y Gastrojejunal Anastomosis on Delayed Gastric Emptying After Pylorus-resecting Pancreaticoduodenectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Cancer
Bile Duct Cancer
Duodenal Cancer
Keywords: Delayed gastric emptying
pancreaticoduodenectomy
Lead sponsor: The First Affiliated Hospital of Xiamen University
Sponsor class: OTHER
Collaborators: name: LanZhou University
name: Eastern Hepatobiliary Surgery Hospital
First posted: 2016-11-03
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients who were scheduled to undergo PD and provided written informed consent.
* In the opinion of the surgeon, the subject has no medical contraindications to PD.
* At least 18 years of age.

Exclusion Criteria:

* Patients who underwent other surgical procedures than PD, such as total pancreatectomy (TP) or a palliative biliary and gastroenteric anastomosis.
* Drug abusers or alcoholics.
* Patient who have previous transabdominal surgery.
* The patient who were scheduled to undergo laparoscopic PD.
* The patient who does not want to participate the clinical trials.

Primary outcomes:
measure: Delayed gastric emptying,rate
timeFrame: 60 days after operation
Secondary outcomes:
measure: Morbidity,rate
timeFrame: 60 days after operation
measure: Mortality,rate
timeFrame: 60 days after operation
measure: Length of hospital stay,days
timeFrame: 60 days after operation
measure: Pancreatic fistula,rate
timeFrame: 60 days after operation
measure: Hemorrhage,rate
timeFrame: 60 days after operation
measure: Bile leakage,rate
timeFrame: 60 days after operation
measure: Intra-abdominal abscess,rate
timeFrame: 60 days after operation
measure: wound infection,rate
timeFrame: 60 days after operation
Other outcomes:
measure: nonsurgical complications,rate
timeFrame: 60 days after operation
Locations:
city: Xiamen
country: China
facility: First affiliated Hospital of Xiamen University
state: Fujian
Study officials:
affiliation: First affiliated Hospital of Xiamen University
name: Yanming Zhou, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barakat O, Cagigas MN, Bozorgui S, Ozaki CF, Wood RP. Proximal Roux-en-y Gastrojejunal Anastomosis with Pyloric Ring Resection Improves Gastric Emptying After Pancreaticoduodenectomy. J Gastrointest Surg. 2016 May;20(5):914-23. doi: 10.1007/s11605-016-3091-5. Epub 2016 Feb 5.