Pancreatic CancerPhase 3NCT01931449
Evaluation of A New Digestive Reconstruction Procedure Following Pancreatoduodenectomy
A Phase 3 study testing Modified method of digestive tract reconstruction and Routine digestive tract reconstruction in people with Pancreatic Cancer and Periampullary Carcinoma, run by Southwest Hospital, China at 1 site in China.
Trial summary
The purpose of this study is to evaluate the validity and safety of a modified operative procedure of digestive tract reconstruction following pancreatoduodenectomy which enables the pancreatic juice and bile to bypass at the pancreatointestinal anastomosis and merge at gastrointestinal anastomosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Cancer, Periampullary Carcinoma
- What is being tested?
- Modified method of digestive tract reconstruction and Routine digestive tract reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Jul 2015
- Phase
- Phase 3
- 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
- Below 80 years old
- CT (Computed Tomography), CTA (Computed Tomographic Angiography), MRI (Magnetic Resonance Imaging) or ultrasonic test suggested pancreatic head carcinoma, periampullary carcinoma, chronic pancreatitis with intractable pain, pancreatic head mass which unable to rule out pancreatic cancer, with or without obstructive jaundice/chronic abdominal pain.
Who cannot join
- Liver Metastasis
- Metastasis in common bile duct and hepatic duct
- Extensive lymph node metastasis, metastasis at hepatic portal or above pancreas
- Pancreatic head or periampullary has tight adhesion with postcava or aorta
- Distant metastasis
- Poor physical condition to tolerate anesthesia and surgery (e.g. severe cardio-pulmonary diseases, blood coagulation disorders)
Trial locations and contacts
1 site in 1 country.
China1 site
Institution of Hepatobiliary Surgery, Southwest Hospital
Chongqing, Chongqing Municipality, 400038
Liang-yu Yin, M.D., 86-23-13937975651, liangyuyin1988@gmail.com
Huai-zhi Wang, M.D., Ph.D
About this study
Official title: Evaluation of a Modified Procedure of Digestive Tract Reconstruction Following Pancreatoduodenectomy: A Multicenter Randomized Controlled Study
The purpose of this study is to evaluate the validity and safety of a modified operative procedure of digestive tract reconstruction following pancreatoduodenectomy which enables the pancreatic juice and bile to bypass at the pancreatointestinal anastomosis and merge at gastrointestinal anastomosis. It is anticipated that this procedure can decrease the risk of post-surgical pancreatic leakage and preserve the patients' digestive function as well.
Read the detailed description
Pancreatoduodenectomy (PD) is one of the most complicated surgeries in abdominal clinical practice. It is widely used in the treatment of pancreatic head carcinoma, periampullary carcinoma, chronic pancreatitis with intractable pain, pancreatic head mass which unable to rule out pancreatic cancer. PD was improved in many ways in the last 80 years and the post-surgical mortality has decreased under 5%. Since the resected region of PD is wide including gall bladder, billiary tract, duodenum, pancreas, stomach, jejunum and regional lymph nodes. It has a high prevalence of complications, of which pancreatic leakage is the most common and serious one with a prevalence rate of 5-25% and mortality rate 20-50%。 The objective of the present study is to evaluate a new surgical procedure used for the digestive tract reconstruction following PD. The new procedure enables the pancreatic juice and bile to bypass at the pancreatointestinal anastomosis and merge at gastrointestinal anastomosis which can decrease the risk of post-surgical pancreatic leakage and keep the digestive function of patients. A multicenter, randomized, controlled study is designed to observe the prevalence of pancreatic leakage, other post-surgical complications, hospital stay, medical costs, life quality and other indexes to evaluate the efficacy and safety of this procedure. It is anticipated that through the study, this new procedure can be systematically verified if it is an ideal procedure of digestive reconstruction following PD which can be promoted into wider use.
- Conditions
- Pancreatic Cancer, Periampullary Carcinoma
- Being tested
- Modified method of digestive tract reconstruction, Routine digestive tract reconstruction
- Keywords
- Pancreatoduodenectomy, Digestive Tract Reconstruction, Pancreas
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified method of digestive tract reconstructionProcedure or surgery
Routine digestive tract reconstructionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Modified digestive reconstruction | Experimental | Modified method of digestive tract reconstruction: Evaluate the resectability; Remove pancreas head, gastric pyloric antrum, duodenum, distal common bile duct and regional lymph nodes; Reconstruct digestive tract with an independent intestinal loop and pancreas end. Receives: Procedure: Modified method of digestive tract reconstruction |
| Routine pancreatoduodenectomy | Active comparator | Routine digestive tract reconstruction: Evaluate the resectability; Remove pancreas head, gastric pyloric antrum, duodenum, distal common bile duct and regional lymph nodes;Reconstruct the common bile duct-jejunum and pancreatic duct-jejunum respectively. Receives: Procedure: Routine digestive tract reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Pancreatic Leakage
Measured: up to 12 months
Secondary outcomes (2)
Life Quality Score
Measured: up to 12 months
Amylase Test of Abdominal Drainage Fluid
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2014 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huai-zhi Wang, Southwest Hospital, China
- Investigators
- Huai-zhi Wang, M.D., Ph.D., Principal investigator, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01931449
- Sponsor's protocol ID
- NDR-2014-01
- Status last verified
- Aug 2013
- First submitted
- 21 Aug 2013
- Last updated
- 29 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Modified Procedure of Digestive Tract Reconstruction Following Pancreatoduodenectomy: A Multicenter Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01931449
- Acronym / sponsor ID
- NDR-2014-01
- Conditions
- Pancreatic Cancer, Periampullary Carcinoma
- Keywords
- Pancreatoduodenectomy, Digestive Tract Reconstruction, Pancreas
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 29 Aug 2013 (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.
The purpose of this study is to evaluate the validity and safety of a modified operative procedure of digestive tract reconstruction following pancreatoduodenectomy which enables the pancreatic juice and bile to bypass at the pancreatointestinal anastomosis and merge at gastrointestinal anastomosis. It is anticipated that this procedure can decrease the risk of post-surgical pancreatic leakage and preserve the patients' digestive function as well.
Detailed description
Pancreatoduodenectomy (PD) is one of the most complicated surgeries in abdominal clinical practice. It is widely used in the treatment of pancreatic head carcinoma, periampullary carcinoma, chronic pancreatitis with intractable pain, pancreatic head mass which unable to rule out pancreatic cancer. PD was improved in many ways in the last 80 years and the post-surgical mortality has decreased under 5%. Since the resected region of PD is wide including gall bladder, billiary tract, duodenum, pancreas, stomach, jejunum and regional lymph nodes. It has a high prevalence of complications, of which pancreatic leakage is the most common and serious one with a prevalence rate of 5-25% and mortality rate 20-50%。 The objective of the present study is to evaluate a new surgical procedure used for the digestive tract reconstruction following PD. The new procedure enables the pancreatic juice and bile to bypass at the pancreatointestinal anastomosis and merge at gastrointestinal anastomosis which can decrease the risk of post-surgical pancreatic leakage and keep the digestive function of patients. A multicenter, randomized, controlled study is designed to observe the prevalence of pancreatic leakage, other post-surgical complications, hospital stay, medical costs, life quality and other indexes to evaluate the efficacy and safety of this procedure. It is anticipated that through the study, this new procedure can be systematically verified if it is an ideal procedure of digestive reconstruction following PD which can be promoted into wider use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified digestive reconstruction | Experimental | Procedure: Modified method of digestive tract reconstructionModified method of digestive tract reconstruction: Evaluate the resectability; Remove pancreas head, gastric pyloric antrum, duodenum, distal common bile duct and regional lymph nodes; Reconstruct digestive tract with an independent intestinal loop and pancreas end. |
| Routine pancreatoduodenectomy | Active comparator | Procedure: Routine digestive tract reconstructionRoutine digestive tract reconstruction: Evaluate the resectability; Remove pancreas head, gastric pyloric antrum, duodenum, distal common bile duct and regional lymph nodes;Reconstruct the common bile duct-jejunum and pancreatic duct-jejunum respectively. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Below 80 years old
- CT (Computed Tomography), CTA (Computed Tomographic Angiography), MRI (Magnetic Resonance Imaging) or ultrasonic test suggested pancreatic head carcinoma, periampullary carcinoma, chronic pancreatitis with intractable pain, pancreatic head mass which unable to rule out pancreatic cancer, with or without obstructive jaundice/chronic abdominal pain.
Key exclusion criteria (6 listed)
- Liver Metastasis
- Metastasis in common bile duct and hepatic duct
- Extensive lymph node metastasis, metastasis at hepatic portal or above pancreas
- Pancreatic head or periampullary has tight adhesion with postcava or aorta
- Distant metastasis
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 |
|---|---|---|
| Modified method of digestive tract reconstruction | Procedure or surgery | Modified digestive reconstruction |
| Routine digestive tract reconstruction | Procedure or surgery | Routine pancreatoduodenectomy |
Primary outcome
Incidence of Pancreatic Leakage
Time frame: up to 12 months
2 secondary outcomes
Life Quality Score
Time frame: up to 12 months
Amylase Test of Abdominal Drainage Fluid
Time frame: up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2013.
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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.
Huai-zhi Wang, M.D., Ph.D. principal investigator
Southwest Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Modified method of digestive tract reconstruction and Routine digestive tract reconstruction in people with Pancreatic Cancer and Periampullary Carcinoma, run by Southwest Hospital, China 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 2 inclusion and 6 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 2013. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Huai-zhi Wang, M.D., Ph.D. (86-23-13996950719, whuaizhi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Pancreatic Leakage (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2013.