Periampullary CarcinomaNCT03083938
Trial of Omental Roll-up Technique on Pancreato-jejunostomy Anastomosis for Reducing Perioperative Complication in Patients Undergoing Pancreatoduodenectomy
A study testing Omental Roll-up in people with Periampullary Carcinoma and Pancreatic Fistula, run by Mahidol University at 1 site in Thailand.
Trial summary
Despite the fact that pancreatoduodenectomy is the standard treatment of malignant tumor at periampullary area, the morbidity and mortality rate with intra-abdominal collection, post pancreatectomy hemorrhage, and delayed gastric emptying, is still high at approximately 50-60%. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Periampullary Carcinoma, Pancreatic Fistula
- What is being tested?
- Omental Roll-up
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 1 Apr 2017to 1 May 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing pancreatoduodenectomy from these disease, carcinoma at head of pancreas, carcinoma at ampullar of Vater, Distal cholangiocarcinoma, Carcinoma of duodenum
Who cannot join
- Unresectable pancreatoduodenectomy
- Patients underwent omentectomy from prior surgery
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Paramin Muangkaew
Bangkok, 10400
Paramin Muangkaew, Doctor, +66860244424, u4102064@gmail.com
Pongsatorn Tangtawee, Doctor, +66931959099, pongsatorn.md@gmail.com
About this study
Official title: Prospective Randomized Controlled Trial of Omental Roll-up Technique on Pancreato-jejunostomy Anastomosis for Reducing Perioperative Complication in Patients Undergoing Pancreatoduodenectomy
Despite the fact that pancreatoduodenectomy is the standard treatment of malignant tumor at periampullary area, the morbidity and mortality rate with intra-abdominal collection, post pancreatectomy hemorrhage, and delayed gastric emptying, is still high at approximately 50-60%. The causes of these complications usually come from post-operative pancreatic fistula. Nowadays, several methods have been reported to reduce the incidence of pancreatic fistula after undergoing pancreatoduodenectomy, such as pancreatic stenting, the use of intravenous somatostatin, the use of sealant material and wrapping anastomosis by soft tissue.
Wrapping pancreato-jejunal anastomosis with omentum is not a complicate procedure and requires no extra treatment expenses of the patient. It has been reported this technique has been applied in the non-randomized controlled trials and their data have significantly shown that the technique could reduce pancreatic fistula rate. Therefore, the researchers want to conduct an RCT study to compare complication rates between omental roll-up pancreato-jejunal anastomosis and non-omental roll-up groups.
Read the detailed description
This is a RCT study designed to compare the use of omental roll-up technique with non-omental roll-up technique at pancreato-jejunal anastomosis in patients undergoing pancreatoduodenectomy. The purpose of this study is to prove the hypothesis that omental roll-up technique can reduce the complication rate or pancratic fistula after pancreatoduodenectomy. This study was approved by the committee on human rights to conduct the research involving human subjects, faculty of medicine Ramathibodi hospital, Mahidol university. The patients are operated by experienced surgeons of Hepato-pancreato-biliary unit, department of surgery, Ramathibodi hospital and randomized into two groups by using the closed envelope method after completing pancreato-jejunal anastomosis. Then, patients are followed-up and the data are collected for 30 days after the surgery.
- Conditions
- Periampullary Carcinoma, Pancreatic Fistula
- Being tested
- Omental Roll-up
- Keywords
- Pancreatoduodenectomy, Omentum, Wrapping, Roll-up, Whipple
- Medical subject headings
- Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omental Roll-upProcedure or surgery
Using omentum roll-up pancreato-jejunal anastomosis
| Study group | Role | What they receive |
|---|---|---|
| Omental Roll-up | Experimental | Not described Receives: Procedure: Omental Roll-up |
| No Omental Roll-up | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rate after using omental roll-up technique
Complication rate after using omental roll-up technique compare with non-omental roll-up
Measured: Within 30 days after surgery
Secondary outcomes (1)
Pancreatic fistula rate after using omental roll-up technique
Pancreatic fistula rate after using omental roll-up technique compare with non-omental roll-up
Measured: Within 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 posted20 Mar 2017
- Study start1 Apr 2017
- Primary completion1 Apr 2019 (estimated)
- Study completion1 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Periampullary CarcinomaStudies of the same condition, open and under way.
- More trials run by Mahidol 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paramin Muangkaew, MD, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03083938
- Sponsor's protocol ID
- ID 12-59-13
- Status last verified
- Aug 2017
- First submitted
- 14 Mar 2017
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sakamoto Y, Shimada K, Esaki M, Kajiwara T, Sano T, Kosuge T. Wrapping the stump of the gastroduodenal artery using the falciform ligament during pancreaticoduodenectomy. J Am Coll Surg. 2007 Feb;204(2):334-6. doi: 10.1016/j.jamcollsurg.2006.11.015. No abstract available.
PubMed 17254940Iannitti DA, Coburn NG, Somberg J, Ryder BA, Monchik J, Cioffi WG. Use of the round ligament of the liver to decrease pancreatic fistulas: a novel technique. J Am Coll Surg. 2006 Dec;203(6):857-64. doi: 10.1016/j.jamcollsurg.2006.08.021. Epub 2006 Oct 25.
PubMed 17116554Ramia JM, de la Plaza R, Adel F, Ramiro C, Arteaga V, Garcia-Parreno J. Wrapping in pancreatic surgery: a systematic review. ANZ J Surg. 2014 Dec;84(12):921-4. doi: 10.1111/ans.12491. Epub 2013 Dec 19.
PubMed 25720806Choi SB, Lee JS, Kim WB, Song TJ, Suh SO, Choi SY. Efficacy of the omental roll-up technique in pancreaticojejunostomy as a strategy to prevent pancreatic fistula after pancreaticoduodenectomy. Arch Surg. 2012 Feb;147(2):145-50. doi: 10.1001/archsurg.2011.865.
PubMed 22351908
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial of Omental Roll-up Technique on Pancreato-jejunostomy Anastomosis for Reducing Perioperative Complication in Patients Undergoing Pancreatoduodenectomy
- ClinicalTrials.gov ID
- NCT03083938
- Acronym / sponsor ID
- ID 12-59-13
- Conditions
- Periampullary Carcinoma, Pancreatic Fistula
- Keywords
- Pancreatoduodenectomy, Omentum, Wrapping, Roll-up, Whipple
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- 1 May 2019 (estimated)
- First posted
- 20 Mar 2017 (actual)
- 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.
Despite the fact that pancreatoduodenectomy is the standard treatment of malignant tumor at periampullary area, the morbidity and mortality rate with intra-abdominal collection, post pancreatectomy hemorrhage, and delayed gastric emptying, is still high at approximately 50-60%. The causes of these complications usually come from post-operative pancreatic fistula. Nowadays, several methods have been reported to reduce the incidence of pancreatic fistula after undergoing pancreatoduodenectomy, such as pancreatic stenting, the use of intravenous somatostatin, the use of sealant material and wrapping anastomosis by soft tissue.
Wrapping pancreato-jejunal anastomosis with omentum is not a complicate procedure and requires no extra treatment expenses of the patient. It has been reported this technique has been applied in the non-randomized controlled trials and their data have significantly shown that the technique could reduce pancreatic fistula rate. Therefore, the researchers want to conduct an RCT study to compare complication rates between omental roll-up pancreato-jejunal anastomosis and non-omental roll-up groups.
Detailed description
This is a RCT study designed to compare the use of omental roll-up technique with non-omental roll-up technique at pancreato-jejunal anastomosis in patients undergoing pancreatoduodenectomy. The purpose of this study is to prove the hypothesis that omental roll-up technique can reduce the complication rate or pancratic fistula after pancreatoduodenectomy. This study was approved by the committee on human rights to conduct the research involving human subjects, faculty of medicine Ramathibodi hospital, Mahidol university. The patients are operated by experienced surgeons of Hepato-pancreato-biliary unit, department of surgery, Ramathibodi hospital and randomized into two groups by using the closed envelope method after completing pancreato-jejunal anastomosis. Then, patients are followed-up and the data are collected for 30 days after the surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omental Roll-up | Experimental | Procedure: Omental Roll-up |
| No Omental Roll-up | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing pancreatoduodenectomy from these disease, carcinoma at head of pancreas, carcinoma at ampullar of Vater, Distal cholangiocarcinoma, Carcinoma of duodenum
Key exclusion criteria (2 listed)
- Unresectable pancreatoduodenectomy
- Patients underwent omentectomy from prior surgery
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 |
|---|---|---|
| Omental Roll-upUsing omentum roll-up pancreato-jejunal anastomosis | Procedure or surgery | Omental Roll-up |
Primary outcome
Complication rate after using omental roll-up technique
Time frame: Within 30 days after surgery
Complication rate after using omental roll-up technique compare with non-omental roll-up
1 secondary outcome
Pancreatic fistula rate after using omental roll-up technique
Time frame: Within 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 29 Aug 2017.
- Background: PubMed 17254940Sakamoto Y, Shimada K, Esaki M, Kajiwara T, Sano T, Kosuge T. Wrapping the stump of the gastroduodenal artery using the falciform ligament during pancreaticoduodenectomy. J Am Coll Surg. 2007 Feb;204(2):334-6. doi: 10.1016/j.jamcollsurg.2006.11.015. No abstract available.
- Background: PubMed 17116554Iannitti DA, Coburn NG, Somberg J, Ryder BA, Monchik J, Cioffi WG. Use of the round ligament of the liver to decrease pancreatic fistulas: a novel technique. J Am Coll Surg. 2006 Dec;203(6):857-64. doi: 10.1016/j.jamcollsurg.2006.08.021. Epub 2006 Oct 25.
- Background: PubMed 25720806Ramia JM, de la Plaza R, Adel F, Ramiro C, Arteaga V, Garcia-Parreno J. Wrapping in pancreatic surgery: a systematic review. ANZ J Surg. 2014 Dec;84(12):921-4. doi: 10.1111/ans.12491. Epub 2013 Dec 19.
- Background: PubMed 22351908Choi SB, Lee JS, Kim WB, Song TJ, Suh SO, Choi SY. Efficacy of the omental roll-up technique in pancreaticojejunostomy as a strategy to prevent pancreatic fistula after pancreaticoduodenectomy. Arch Surg. 2012 Feb;147(2):145-50. doi: 10.1001/archsurg.2011.865.
- 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 Omental Roll-up in people with Periampullary Carcinoma and Pancreatic Fistula, run by Mahidol University at 1 site in Thailand.
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 1 inclusion and 2 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 29 Aug 2017. 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 Thailand. 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 Paramin Muangkaew, Doctor (+66860244424, u4102064@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication rate after using omental roll-up technique (time frame: Within 30 days 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 NCT03083938, which also lists 4 linked publications.
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 29 Aug 2017.