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

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

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).

Study Overview

• Status: Unknown
• Conditions: Pancreatic Cancer; Bile Duct Cancer; Duodenal Cancer
• Intervention / Treatment: Procedure: PrPD with proximal Roux-en-y gastrojejunal anastomosis; Procedure: conventional 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 Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China, 361003
      • Recruiting
      • First Affiliated Hospital of Xiamen University
      • Contact: Minqiang Lin, Dr; Phone Number: 8605922139908 8605922139708; Email: 80218353@qq.com
      • Principal Investigator: Yanming Zhou, Dr
      • Sub-Investigator: Xiaofeng Zhang, Dr
      • Sub-Investigator: Feng Yu, Dr
      • Sub-Investigator: Lupeng Wu, Dr
      • Sub-Investigator: AIling Song, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PrPD with RGA; Patients who will undergo PrPD with proximal Roux-en-y gastrojejunal anastomosis.	Procedure: PrPD with proximal Roux-en-y gastrojejunal anastomosis; 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).
Experimental: conventional PrPD; Patients who will undergo conventional PrPD.	Procedure: conventional PrPD; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	60 days after operation

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
nonsurgical complications,rate	60 days after operation

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Xiamen University
• Collaborators: LanZhou University; Eastern Hepatobiliary Surgery Hospital
• Investigators: Principal Investigator: Yanming Zhou, Dr, First Affiliated Hospital of Xiamen University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: September 7, 2016
• First Submitted That Met QC Criteria: November 1, 2016
• First Posted (Estimate): November 3, 2016

Study Record Updates

• Last Update Posted (Estimate): November 3, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: pancreaticoduodenectomy; Delayed gastric emptying
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neurologic Manifestations; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Intestinal Neoplasms; Duodenal Diseases; Biliary Tract Diseases; Paralysis; Bile Duct Diseases; Biliary Tract Neoplasms; Cholangiocarcinoma; Gastroparesis; Bile Duct Neoplasms; Duodenal Neoplasms
• Other Study ID Numbers: FAHXMU-2016-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to make individual participant data.