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

Not Applicable

• Conditions: Pancreatic Cancer; Duodenal Cancer; Bile Duct Cancer
• Interventions: Procedure: PrPD with proximal Roux-en-y gastrojejunal anastomosis; Procedure: conventional PrPD

• Registration Number: NCT02954302
• Lead Sponsor: The First Affiliated Hospital of Xiamen University

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-07
• Status Verified: 2016-11
• Study First Submitted QC: 2016-11-01
• Last Update Submitted: 2016-11-01
• Study First Posted: 2016-11-03
• Last Update Posted: 2016-11-03
• Primary Completion: 2018-11
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PrPD with RGA	PrPD with proximal Roux-en-y gastrojejunal anastomosis	Patients who will undergo PrPD with proximal Roux-en-y gastrojejunal anastomosis.
conventional PrPD	conventional PrPD	Patients who will undergo conventional PrPD.

Primary Outcome Measures

Name	Time	Method
Delayed gastric emptying,rate	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.

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay,days	60 days after operation
wound infection,rate	60 days after operation
Intra-abdominal abscess,rate	60 days after operation
Hemorrhage,rate	60 days after operation
Bile leakage,rate	60 days after operation
Pancreatic fistula,rate	60 days after operation
Morbidity,rate	60 days after operation
Mortality,rate	60 days after operation

Trial Locations

Locations (1)

First affiliated Hospital of Xiamen University; 🇨🇳 Xiamen, Fujian, China