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

NCT ID: NCT02954302

Last Updated: 2016-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Pancreatic Cancer Bile Duct Cancer Duodenal Cancer

Keywords

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Delayed gastric emptying pancreaticoduodenectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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PrPD with RGA

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

Group Type EXPERIMENTAL

PrPD with proximal Roux-en-y gastrojejunal anastomosis

Intervention Type PROCEDURE

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).

conventional PrPD

Patients who will undergo conventional PrPD.

Group Type EXPERIMENTAL

conventional PrPD

Intervention Type PROCEDURE

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.

Interventions

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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).

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LanZhou University

OTHER

Sponsor Role collaborator

Eastern Hepatobiliary Surgery Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Xiamen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yanming Zhou, Dr

Role: PRINCIPAL_INVESTIGATOR

First affiliated Hospital of Xiamen University

Locations

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First affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Mingqiang Lin, Dr

Role: CONTACT

Phone: 8605922139708

Email: [email protected]

Yanming Zhou, Dr

Role: CONTACT

Phone: 8605922139708

Email: [email protected]

Facility Contacts

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Minqiang Lin, Dr

Role: primary

References

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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.

Reference Type RESULT
PMID: 26850262 (View on PubMed)

Other Identifiers

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FAHXMU-2016-04

Identifier Type: -

Identifier Source: org_study_id