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

Primary Purpose

Pancreatic Cancer, Bile Duct Cancer, Duodenal Cancer

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

PrPD with proximal Roux-en-y gastrojejunal anastomosis

conventional PrPD

About this trial

This is an interventional prevention trial for Pancreatic Cancer focused on measuring Delayed gastric emptying, pancreaticoduodenectomy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

First affiliated Hospital of Xiamen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

PrPD with RGA

conventional PrPD

Arm Description

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

Patients who will undergo conventional PrPD.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Morbidity,rate

Mortality,rate

Length of hospital stay,days

Pancreatic fistula,rate

Hemorrhage,rate

Bile leakage,rate

Intra-abdominal abscess,rate

wound infection,rate

Full Information

NCT ID

NCT02954302

First Posted

September 7, 2016

Last Updated

November 1, 2016

Sponsor

The First Affiliated Hospital of Xiamen University

Collaborators

LanZhou University, Eastern Hepatobiliary Surgery Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02954302

Brief Title

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

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Unknown status

Study Start Date

September 2016 (undefined)

Primary Completion Date

November 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The First Affiliated Hospital of Xiamen University

Collaborators

LanZhou University, Eastern Hepatobiliary Surgery Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer, Bile Duct Cancer, Duodenal Cancer

Keywords

Delayed gastric emptying, pancreaticoduodenectomy

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PrPD with RGA

Arm Type

Experimental

Arm Description

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

Arm Title

conventional PrPD

Arm Type

Experimental

Arm Description

Patients who will undergo conventional PrPD.

Intervention Type

Procedure

Intervention Name(s)

PrPD with proximal Roux-en-y gastrojejunal anastomosis

Intervention Description

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).

Intervention Type

Procedure

Intervention Name(s)

conventional PrPD

Intervention Description

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.

Primary Outcome Measure Information:

Title

Delayed gastric emptying,rate

Description

Time Frame

60 days after operation

Secondary Outcome Measure Information:

Title

Morbidity,rate

Time Frame

60 days after operation

Title

Mortality,rate

Time Frame

60 days after operation

Title

Length of hospital stay,days

Time Frame

60 days after operation

Title

Pancreatic fistula,rate

Time Frame

60 days after operation

Title

Hemorrhage,rate

Time Frame

60 days after operation

Title

Bile leakage,rate

Time Frame

60 days after operation

Title

Intra-abdominal abscess,rate

Time Frame

60 days after operation

Title

wound infection,rate

Time Frame

60 days after operation

Other Pre-specified Outcome Measures:

Title

nonsurgical complications,rate

Time Frame

60 days after operation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mingqiang Lin, Dr

Phone

8605922139708

80218353@qq.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yanming Zhou, Dr

Phone

8605922139708

zhouymsxy@sina.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yanming Zhou, Dr

Organizational Affiliation

First affiliated Hospital of Xiamen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

First affiliated Hospital of Xiamen University

City

Xiamen

State/Province

Fujian

ZIP/Postal Code

361003

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Minqiang Lin, Dr

Phone

8605922139708

Ext

8605922139908

80218353@qq.com

First Name & Middle Initial & Last Name & Degree

Yanming Zhou, Dr

First Name & Middle Initial & Last Name & Degree

Xiaofeng Zhang, Dr

First Name & Middle Initial & Last Name & Degree

Feng Yu, Dr

First Name & Middle Initial & Last Name & Degree

Lupeng Wu, Dr

First Name & Middle Initial & Last Name & Degree

AIling Song, Dr

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

There is no plan to make individual participant data.

Citations:

PubMed Identifier

26850262

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.

Results Reference

result

Learn more about this trial

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

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