Pancreatic CancerNCT02954302
Proximal Roux-en-y Gastrojejunal Anastomosis on Delayed Gastric Emptying After Pylorus-resecting Pancreaticoduodenectomy
A study testing PrPD with proximal Roux-en-y gastrojejunal anastomosis and conventional PrPD in people with Pancreatic Cancer and Bile Duct Cancer, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Cancer, Bile Duct Cancer, Duodenal Cancer
- What is being tested?
- PrPD with proximal Roux-en-y gastrojejunal anastomosis and conventional PrPD
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
Minqiang Lin, Dr, 8605922139708 ext. 8605922139908, 80218353@qq.com
Yanming Zhou, Dr
About this study
Official title: 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).
Read the 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.
- Conditions
- Pancreatic Cancer, Bile Duct Cancer, Duodenal Cancer
- Being tested
- PrPD with proximal Roux-en-y gastrojejunal anastomosis, conventional PrPD
- Keywords
- Delayed gastric emptying, pancreaticoduodenectomy
- Medical subject headings
- Pancreatic Neoplasms, Bile Duct Neoplasms, Duodenal Neoplasms, Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrPD with proximal Roux-en-y gastrojejunal anastomosisProcedure or surgery
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 PrPDProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| PrPD with RGA | Experimental | Patients who will undergo PrPD with proximal Roux-en-y gastrojejunal anastomosis. Receives: Procedure: PrPD with proximal Roux-en-y gastrojejunal anastomosis |
| conventional PrPD | Experimental | Patients who will undergo conventional PrPD. Receives: Procedure: conventional PrPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 days after operation
Secondary outcomes (8)
Morbidity,rate
Measured: 60 days after operation
Mortality,rate
Measured: 60 days after operation
Length of hospital stay,days
Measured: 60 days after operation
Pancreatic fistula,rate
Measured: 60 days after operation
Hemorrhage,rate
Measured: 60 days after operation
Bile leakage,rate
Measured: 60 days after operation
Intra-abdominal abscess,rate
Measured: 60 days after operation
wound infection,rate
Measured: 60 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2016 (estimated)
- Study startSep 2016
- Primary completionNov 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- LanZhou University, Eastern Hepatobiliary Surgery Hospital
- Responsible party
- Sponsor
- Investigators
- Yanming Zhou, Dr, Principal investigator, First affiliated Hospital of Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02954302
- Sponsor's protocol ID
- FAHXMU-2016-04
- Status last verified
- Nov 2016
- First submitted
- 7 Sep 2016
- Last updated
- 3 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: There is no plan to make individual participant data.
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.
PubMed 26850262
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proximal Roux-en-y Gastrojejunal Anastomosis on Delayed Gastric Emptying After Pylorus-resecting Pancreaticoduodenectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02954302
- Acronym / sponsor ID
- FAHXMU-2016-04
- Conditions
- Pancreatic Cancer, Bile Duct Cancer, Duodenal Cancer
- Keywords
- Delayed gastric emptying, pancreaticoduodenectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Collaborators
- LanZhou University, Eastern Hepatobiliary Surgery Hospital
- Study start
- Sep 2016
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 3 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PrPD with RGA | Experimental | Procedure: PrPD with proximal Roux-en-y gastrojejunal anastomosisPatients who will undergo PrPD with proximal Roux-en-y gastrojejunal anastomosis. |
| conventional PrPD | Experimental | Procedure: conventional PrPDPatients who will undergo conventional PrPD. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrPD with proximal Roux-en-y gastrojejunal anastomosisthe 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). | Procedure or surgery | PrPD with RGA |
| conventional PrPDAfter 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. | Procedure or surgery | conventional PrPD |
Primary outcome
Delayed gastric emptying,rate
Time frame: 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.
8 secondary outcomes
Morbidity,rate
Time frame: 60 days after operation
Mortality,rate
Time frame: 60 days after operation
Length of hospital stay,days
Time frame: 60 days after operation
Pancreatic fistula,rate
Time frame: 60 days after operation
Hemorrhage,rate
Time frame: 60 days after operation
Bile leakage,rate
Time frame: 60 days after operation
Intra-abdominal abscess,rate
Time frame: 60 days after operation
wound infection,rate
Time frame: 60 days after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2016.
- Results publication: PubMed 26850262Barakat 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.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanming Zhou, Dr principal investigator
First affiliated Hospital of Xiamen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrPD with proximal Roux-en-y gastrojejunal anastomosis and conventional PrPD in people with Pancreatic Cancer and Bile Duct Cancer, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mingqiang Lin, Dr (8605922139708, 80218353@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delayed gastric emptying,rate (time frame: 60 days after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02954302, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2016.