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

Xiamen University

Status: Unknown

Conditions: Bile Duct Cancer; Duodenal Cancer; Pancreatic Cancer

Treatments: Procedure: PrPD with proximal Roux-en-y gastrojejunal anastomosis; Procedure: conventional PrPD

Study type: Interventional

Funder types: Other

Identifiers

NCT02954302

FAHXMU-2016-04

Details and patient eligibility

About

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).

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

PrPD with RGA

Experimental group

Description:

Patients who will undergo PrPD with proximal Roux-en-y gastrojejunal anastomosis.

Treatment:

Procedure: PrPD with proximal Roux-en-y gastrojejunal anastomosis

conventional PrPD

Experimental group

Description:

Patients who will undergo conventional PrPD.

Treatment:

Procedure: conventional PrPD