Delayed Gastric EmptyingNCT02635399
Impact of Additional DJ (Duodenojejunostomy)-Pexy on Reduction in Delayed Gastric Emptying Following Pylorus-preserving Pancreaticoduodenectomy: A Prospective, Randomized Controlled Trial
A study testing PPPD (pylorus-preserving pancreaticoduodenectomy) and PPPD (pylorus-preserving pancreaticoduodenectomy) with DJ-pexy in people with Delayed Gastric Emptying, run by Yonsei University at 1 site in South Korea.
Trial summary
Surgical resection in periampullary cancer using pancreaticoduodenectomy is the most important modality in the treatment. In the past, pancreaticoduodenectomy was associated with high morbidity and mortality. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Delayed Gastric Emptying
- What is being tested?
- PPPD (pylorus-preserving pancreaticoduodenectomy) and PPPD (pylorus-preserving pancreaticoduodenectomy) with DJ-pexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2016to Dec 2019
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All periampullary pathologic conditions that require PPPD
- Age ≥20 and ≤80
- General performance status: the Karnofsky score> 70% or ECOG 0-1
Who cannot join
- Unresectable or locally advanced, metastatic case
- patients who do not want surgery
- ASA (American society of anesthesiologists' physical status classification) score: ≥3
- patients with drug or alcohol addiction
- patients showing low compliance
- patients who not want to involve the clinical trial
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- patients who are unable to read or understand the informed consent, sign a consent form (eg, mental retardation, blindness, illiteracy, foreign, etc.)
- pylorus can not be preserved
- Patients undergoing laparoscopic PPPD
- Additional resection of adjacent organs or vascular resection was performed
- Previous history of open surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital
Seoul, 120-752
Chang Moo Kang, MD, 82-2-2228-2100, cmkang@yuhs.ac
About this study
Surgical resection in periampullary cancer using pancreaticoduodenectomy is the most important modality in the treatment. In the past, pancreaticoduodenectomy was associated with high morbidity and mortality. However, with the advances in techniques, including perioperative patient management, development of antibiotics, diagnostic radiology, and interventional treatments, pancreaticoduodenectomy is now considered a safe and feasible operation. Postoperative complication rates are reported to be in 10 to 20% in experienced hospitals and operation related mortality is at about 1%. Therefore, surgical treatment for periampullary cancer is actively considered.
However, postoperative complications, such as postoperative pancreatic fistula, (POPF) delayed gastric emptying, intraabdominal abscess, and postoperative bleeding, are still serious complications. Among these complications, delayed gastric emptying is considered less critical. However, delayed gastric emptying (DGE) can cause poor oral intake, which in turn, may lead to delay in recovery of postoperative nutritional state and in severe cases, requires insertion of levine tube and long-term fasting.
Read more
There have been many hypotheses for cause of DGE after pancreaticoduodenectomy, but definite cause have not been discovered yet. With the introduction of pylorus-preserving pancreaticoduodenectomy (PPPD), incidences of DGE were initially reported to have increased. However, results of most randomized comparative studies had concluded that PPPD and PD have no significance in occurence of DGE.
One hypothesis for cause of DGE we present here has to do with anatomic positioning of anastomosis site, especially pancreatojejunostomy (PJ) and duodenojejunostomy (DJ), after PPPD. Reconstruction after PPPD positions PJ and DJ close to each other. PJ site is often associated with one of postoperative complications, POPF. POPF may create inflammation around PJ site and pancreatitis, which may lead to severe adhesion around PJ as a secondary change. This adhesion and inflammation may cause DJ, which is located near PJ, to be pulled towards PJ site. When DJ is pulled towards PJ site, distal DJ site can become angulated and gastric contents may not beadle to pass easily. Gastric contents may be stagnated in stomach and thereby causing DGE. Therefore, in this study, we will fixate DJ on transverse colon using sutures, and prevent possibility of angulation of DJ. This additional procedure may reduce occurence of DGE.
- Conditions
- Delayed Gastric Emptying
- Being tested
- PPPD (pylorus-preserving pancreaticoduodenectomy), PPPD (pylorus-preserving pancreaticoduodenectomy) with DJ-pexy
- Keywords
- pancreaticoduodenectomy, delayed gastric emptying, duodenojejunopexy
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPPD (pylorus-preserving pancreaticoduodenectomy)Procedure or surgery
pylorus-preserving pancreaticoduodenectomy is done in a conventional method. Additional DJ-pexy is performed for experimental group. DJ-pexy is performed by anchoring DJ site to transverse colon so that DJ is fixed to its original position.
PPPD (pylorus-preserving pancreaticoduodenectomy) with DJ-pexyProcedure or surgery
pylorus-preserving pancreaticoduodenectomy is done in a conventional method. Additional DJ-pexy is performed for experimental group. DJ-pexy is performed by anchoring DJ site to transverse colon so that DJ is fixed to its original position.
| Study group | Role | What they receive |
|---|---|---|
| conventional group | Placebo comparator | Conventional PPPD Receives: Procedure: PPPD (pylorus-preserving pancreaticoduodenectomy) |
| DJ-pexy group | Experimental | PPPD with additional DJ-pexy to anchor DJ to transverse colon Receives: Procedure: PPPD (pylorus-preserving pancreaticoduodenectomy) with DJ-pexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of clinically relevant DGE
DGE is defined by International Study Group of Pancreatic Surgery consensus definition. Clinically relevant grade B or C will be recorded and occurrence rate of DGE between the arms will be compared.
Measured: With the first 30days after surgery
Secondary outcomes (1)
Risk factors influencing DGE
Preoperative, intraoperative, and postoperative variables will analyzed statistically between the arms
Measured: Within the first 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study start1 Jan 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (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 Delayed Gastric EmptyingStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635399
- Sponsor's protocol ID
- 4-2015-0969
- Status last verified
- Mar 2019
- First submitted
- 15 Dec 2015
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Khan AS, Hawkins WG, Linehan DC, Strasberg SM. A technique of gastrojejunostomy to reduce delayed gastric emptying after pancreatoduodenectomy. J Gastrointest Surg. 2011 Aug;15(8):1468-71. doi: 10.1007/s11605-011-1471-4. Epub 2011 Feb 24.
PubMed 21347870
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Additional DJ (Duodenojejunostomy)-Pexy on Reduction in Delayed Gastric Emptying Following Pylorus-preserving Pancreaticoduodenectomy: A Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02635399
- Acronym / sponsor ID
- 4-2015-0969
- Conditions
- Delayed Gastric Emptying
- Keywords
- pancreaticoduodenectomy, delayed gastric emptying, duodenojejunopexy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 18 Dec 2015 (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.
Surgical resection in periampullary cancer using pancreaticoduodenectomy is the most important modality in the treatment. In the past, pancreaticoduodenectomy was associated with high morbidity and mortality. However, with the advances in techniques, including perioperative patient management, development of antibiotics, diagnostic radiology, and interventional treatments, pancreaticoduodenectomy is now considered a safe and feasible operation. Postoperative complication rates are reported to be in 10 to 20% in experienced hospitals and operation related mortality is at about 1%. Therefore, surgical treatment for periampullary cancer is actively considered.
However, postoperative complications, such as postoperative pancreatic fistula, (POPF) delayed gastric emptying, intraabdominal abscess, and postoperative bleeding, are still serious complications. Among these complications, delayed gastric emptying is considered less critical. However, delayed gastric emptying (DGE) can cause poor oral intake, which in turn, may lead to delay in recovery of postoperative nutritional state and in severe cases, requires insertion of levine tube and long-term fasting.
There have been many hypotheses for cause of DGE after pancreaticoduodenectomy, but definite cause have not been discovered yet. With the introduction of pylorus-preserving pancreaticoduodenectomy (PPPD), incidences of DGE were initially reported to have increased. However, results of most randomized comparative studies had concluded that PPPD and PD have no significance in occurence of DGE.
One hypothesis for cause of DGE we present here has to do with anatomic positioning of anastomosis site, especially pancreatojejunostomy (PJ) and duodenojejunostomy (DJ), after PPPD. Reconstruction after PPPD positions PJ and DJ close to each other. PJ site is often associated with one of postoperative complications, POPF. POPF may create inflammation around PJ site and pancreatitis, which may lead to severe adhesion around PJ as a secondary change. This adhesion and inflammation may cause DJ, which is located near PJ, to be pulled towards PJ site. When DJ is pulled towards PJ site, distal DJ site can become angulated and gastric contents may not beadle to pass easily. Gastric contents may be stagnated in stomach and thereby causing DGE. Therefore, in this study, we will fixate DJ on transverse colon using sutures, and prevent possibility of angulation of DJ. This additional procedure may reduce occurence of DGE.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional group | Placebo comparator | Procedure: PPPD (pylorus-preserving pancreaticoduodenectomy)Conventional PPPD |
| DJ-pexy group | Experimental | Procedure: PPPD (pylorus-preserving pancreaticoduodenectomy) with DJ-pexyPPPD with additional DJ-pexy to anchor DJ to transverse colon |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All periampullary pathologic conditions that require PPPD
- Age ≥20 and ≤80
- General performance status: the Karnofsky score> 70% or ECOG 0-1
Key exclusion criteria (11 listed)
- Unresectable or locally advanced, metastatic case
- patients who do not want surgery
- ASA (American society of anesthesiologists' physical status classification) score: ≥3
- patients with drug or alcohol addiction
- patients showing low compliance
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 |
|---|---|---|
| PPPD (pylorus-preserving pancreaticoduodenectomy)pylorus-preserving pancreaticoduodenectomy is done in a conventional method. Additional DJ-pexy is performed for experimental group. DJ-pexy is performed by anchoring DJ site to transverse colon so that DJ is fixed to its original position. | Procedure or surgery | conventional group |
| PPPD (pylorus-preserving pancreaticoduodenectomy) with DJ-pexypylorus-preserving pancreaticoduodenectomy is done in a conventional method. Additional DJ-pexy is performed for experimental group. DJ-pexy is performed by anchoring DJ site to transverse colon so that DJ is fixed to its original position. | Procedure or surgery | DJ-pexy group |
Primary outcome
Occurence of clinically relevant DGE
Time frame: With the first 30days after surgery
DGE is defined by International Study Group of Pancreatic Surgery consensus definition. Clinically relevant grade B or C will be recorded and occurrence rate of DGE between the arms will be compared.
1 secondary outcome
Risk factors influencing DGE
Time frame: Within the first 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Background: PubMed 21347870Khan AS, Hawkins WG, Linehan DC, Strasberg SM. A technique of gastrojejunostomy to reduce delayed gastric emptying after pancreatoduodenectomy. J Gastrointest Surg. 2011 Aug;15(8):1468-71. doi: 10.1007/s11605-011-1471-4. Epub 2011 Feb 24.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PPPD (pylorus-preserving pancreaticoduodenectomy) and PPPD (pylorus-preserving pancreaticoduodenectomy) with DJ-pexy in people with Delayed Gastric Emptying, run by Yonsei University at 1 site in South Korea.
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 11 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 26 Mar 2019. 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 South Korea. 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. Some participants in this study may receive a placebo. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurence of clinically relevant DGE (time frame: With the first 30days after surgery). 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 NCT02635399, 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 26 Mar 2019; AzTrials last refreshed its copy on 7 Nov 2026.