Proximal Roux-en-y Gastrojejunal Anastomosis on Delayed Gastric Emptying After Pylorus-resecting Pancreaticoduodenectomy
1 other identifier
interventional
140
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable pancreatic-cancer
Started Sep 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 7, 2016
CompletedFirst Posted
Study publicly available on registry
November 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedNovember 3, 2016
November 1, 2016
2.2 years
September 7, 2016
November 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
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
- +3 more secondary outcomes
Other Outcomes (1)
nonsurgical complications,rate
60 days after operation
Study Arms (2)
PrPD with RGA
EXPERIMENTALPatients who will undergo PrPD with proximal Roux-en-y gastrojejunal anastomosis.
conventional PrPD
EXPERIMENTALPatients who will undergo conventional PrPD.
Interventions
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).
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The First Affiliated Hospital of Xiamen Universitylead
- LanZhou Universitycollaborator
- Eastern Hepatobiliary Surgery Hospitalcollaborator
Study Sites (1)
First affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
Related Publications (1)
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.
PMID: 26850262RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yanming Zhou, Dr
First affiliated Hospital of Xiamen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2016
First Posted
November 3, 2016
Study Start
September 1, 2016
Primary Completion
November 1, 2018
Study Completion
December 1, 2018
Last Updated
November 3, 2016
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will not share
There is no plan to make individual participant data.