Periampullary Carcinoma NosNCT01291927
Pancreas-sparing Duodenectomy Versus Pancreatoduodenectomy for Early-stage Periampullary Carcinoma
A study testing Pancreas-sparing duodenectomy and Pancreaticoduodenectomy in people with Periampullary Carcinoma Nos, run by Southwest Hospital, China at 1 site in China.
Trial summary
The purpose of this study is to investigate the feasibility, safety, and long-term prognosis of pancreas-sparing duodenectomy with regional lymphadenectomy in the treatment of early-stage (pTis/pT1/pT2) periampullary carcinoma with or without lymph node metastasis Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Periampullary Carcinoma Nos
- What is being tested?
- Pancreas-sparing duodenectomy and Pancreaticoduodenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- May 2005to May 2015
- 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
- Pathologically proven periampullary carcinoma (including cancers of distal common bile duct, ampulla or papilla of Vater)
- Pre- and intra-operative stage(CT, EU stage):pTis or pT1 or pT2, N0 or N1, M0
- ASA score: < 3
- Liver function:Child-Pugh A
- No history of other cancers
- No history of preoperative chemotherapy or radiotherapy
- Written informed consent
Who cannot join
- There are concurrent cancers or the patients have been treated due to other type of cancers before diagnosed as periampullary carcinoma
- Pre- and intra-operative stage: more advanced than T2,or with remote metastasis
- The Patients received other non-surgical therapy, such as chemotherapy, immunotherapy, radiotherapy or endoscopic therapy
- The Patients received upper abdominal surgery
- ASA score: ≥ 3
- Liver function:Child-Pugh B or C
- Pregnancy patients
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Institute of Hepatobiliary Surgery, Southwest Hospital,Third Military Medical University
Chongqing, Chongqing Municipality, 400038
Geng Chen, M.D.,Ph.D., 86-0-13996418308, chengeng@medmail.com.cn
About this study
Official title: Comparison of Pancreas-sparing Duodenectomy With Pancreatoduodenectomy for Early-stage Periampullary Carcinoma:A Prospective Non-Randomized Trial
The purpose of this study is to investigate the feasibility, safety, and long-term prognosis of pancreas-sparing duodenectomy with regional lymphadenectomy in the treatment of early-stage (pTis/pT1/pT2) periampullary carcinoma with or without lymph node metastasis
Read the detailed description
Pancreaticoduodenectomy (PD) is commonly used for periampullary carcinoma (PC). In recent years, morbidity and mortality rates following PD have decreased, but the operative stress induced by pancreatectomy is considerable. Less-invasive surgery should thus be elected for PC without pancreatic and diffuse lymph node involvement. From the perspective of organ-preserving resection, pancreas-sparing duodenectomy (PSD) represents an attractive option for selected periampullary tumors, and offers an alternative to PD.
Previous reports have described PSD for benign, premalignant and some selected malignant conditions of duodenum, and have emphasized this procedure as a safe and effective treatment associated with good quality of life. However, use of PSD for PC is still controversial.Available data about PSD for PC and published data from the follow-up evaluation in the literature are still limited.
Given the fact that 20%-60% pT1/pT2 patients have regional lymph node metastasis, regional lymph node dissection should be essential for PC. However, lymphadenectomy has never been promoted as a regular procedure of PSD.The aim of the present study was to investigate the feasibility, safety, and long-term results of PSD with regional lymphadenectomy for early-stage (pTis/pT1/pT2) periampullary cancers.
- Conditions
- Periampullary Carcinoma Nos
- Being tested
- Pancreas-sparing duodenectomy, Pancreaticoduodenectomy
- Keywords
- Periampullary carcinoma, Pancreas-sparing Duodenectomy, pancreaticoduodenectomy, lymphadenectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreas-sparing duodenectomyProcedure or surgery
Also called PSD
Pancreas-sparing duodenectomy for periampullary carcinoma is defined as resection of the descending segment of duodenum; resection of papilla of Vater; reimplantation of bile and pancreatic ducts and reconstruction of duodenum.The Japan Pancreatic Society (JPS) system for numbering of lymph node stations was adopted for accurate description of the surgery and pathological assessment.The standard lymph node groups removed as part of PSD were the anterior pancreatoduodenal groups (JPS LN17), the posterior pancreatoduodenal groups (JPS LN13), the dextroinferior nodes of the hepatoduodenal ligament node groups (JPS LN12), the infrapyloric node (JPS LN6), the nodes around the anterior aspect of the common hepatic artery (JPS LN8) and the nodes on the right side of the SMA (JPS LN14).
PancreaticoduodenectomyProcedure or surgery
Also called PD
The surgical technique used for standard PD has been described before. Standard PD included clearance of all soft tissues and lymphatics immediately to the left of the superior mesenteric artery, as well as removal of the lymphoareolar tissue along the proximal hepatic artery.
| Study group | Role | What they receive |
|---|---|---|
| Pancreas-sparing duodenectomy | Experimental | Not described Receives: Procedure: Pancreas-sparing duodenectomy |
| Pancreaticoduodenectomy | Active comparator | Not described Receives: Procedure: Pancreaticoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
It is an average time peroid.
Measured: 5 years
Secondary outcomes (1)
Number of Patients with early postoperative complications as a Measure of Safety and Tolerability
Early postoperative complications consist of gastrointestinal/abdominal bleeding, pancreatic leakage, encephalopathy, delayed gastric emptying, diabetes mellitus and wound infection
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startMay 2005
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periampullary Carcinoma NosStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Investigators
- Ping Bie, M.D.,Ph.D., Study director, Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical UniversityGeng Chen, M.D.,Ph.D., Principal investigator, Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291927
- Sponsor's protocol ID
- HBS-PSU-001
- Status last verified
- Jan 2011
- First submitted
- 8 Feb 2011
- Last updated
- 9 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pancreas-sparing Duodenectomy With Pancreatoduodenectomy for Early-stage Periampullary Carcinoma:A Prospective Non-Randomized Trial
- ClinicalTrials.gov ID
- NCT01291927
- Acronym / sponsor ID
- HBS-PSU-001
- Conditions
- Periampullary Carcinoma Nos
- Keywords
- Periampullary carcinoma, Pancreas-sparing Duodenectomy, pancreaticoduodenectomy, lymphadenectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 9 Feb 2011 (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 investigate the feasibility, safety, and long-term prognosis of pancreas-sparing duodenectomy with regional lymphadenectomy in the treatment of early-stage (pTis/pT1/pT2) periampullary carcinoma with or without lymph node metastasis
Detailed description
Pancreaticoduodenectomy (PD) is commonly used for periampullary carcinoma (PC). In recent years, morbidity and mortality rates following PD have decreased, but the operative stress induced by pancreatectomy is considerable. Less-invasive surgery should thus be elected for PC without pancreatic and diffuse lymph node involvement. From the perspective of organ-preserving resection, pancreas-sparing duodenectomy (PSD) represents an attractive option for selected periampullary tumors, and offers an alternative to PD.
Previous reports have described PSD for benign, premalignant and some selected malignant conditions of duodenum, and have emphasized this procedure as a safe and effective treatment associated with good quality of life. However, use of PSD for PC is still controversial.Available data about PSD for PC and published data from the follow-up evaluation in the literature are still limited.
Given the fact that 20%-60% pT1/pT2 patients have regional lymph node metastasis, regional lymph node dissection should be essential for PC. However, lymphadenectomy has never been promoted as a regular procedure of PSD.The aim of the present study was to investigate the feasibility, safety, and long-term results of PSD with regional lymphadenectomy for early-stage (pTis/pT1/pT2) periampullary cancers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pancreas-sparing duodenectomy | Experimental | Procedure: Pancreas-sparing duodenectomy |
| Pancreaticoduodenectomy | Active comparator | Procedure: Pancreaticoduodenectomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pathologically proven periampullary carcinoma (including cancers of distal common bile duct, ampulla or papilla of Vater)
- Pre- and intra-operative stage(CT, EU stage):pTis or pT1 or pT2, N0 or N1, M0
- ASA score: < 3
- Liver function:Child-Pugh A
- No history of other cancers
Key exclusion criteria (7 listed)
- There are concurrent cancers or the patients have been treated due to other type of cancers before diagnosed as periampullary carcinoma
- Pre- and intra-operative stage: more advanced than T2,or with remote metastasis
- The Patients received other non-surgical therapy, such as chemotherapy, immunotherapy, radiotherapy or endoscopic therapy
- The Patients received upper abdominal surgery
- ASA score: ≥ 3
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 |
|---|---|---|
| Pancreas-sparing duodenectomyAlso: PSDPancreas-sparing duodenectomy for periampullary carcinoma is defined as resection of the descending segment of duodenum; resection of papilla of Vater; reimplantation of bile and pancreatic ducts and reconstruction of duodenum.The Japan Pancreatic Society (JPS) system for numbering of lymph node stations was adopted for accurate description of the surgery and pathological assessment.The standard lymph node groups removed as part of PSD were the anterior pancreatoduodenal groups (JPS LN17), the posterior pancreatoduodenal groups (JPS LN13), the dextroinferior nodes of the hepatoduodenal ligament node groups (JPS LN12), the infrapyloric node (JPS LN6), the nodes around the anterior aspect of the common hepatic artery (JPS LN8) and the nodes on the right side of the SMA (JPS LN14). | Procedure or surgery | Pancreas-sparing duodenectomy |
| PancreaticoduodenectomyAlso: PDThe surgical technique used for standard PD has been described before. Standard PD included clearance of all soft tissues and lymphatics immediately to the left of the superior mesenteric artery, as well as removal of the lymphoareolar tissue along the proximal hepatic artery. | Procedure or surgery | Pancreaticoduodenectomy |
Primary outcome
Disease free survival
Time frame: 5 years
It is an average time peroid.
1 secondary outcome
Number of Patients with early postoperative complications as a Measure of Safety and Tolerability
Time frame: up to 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2011.
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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.
Ping Bie, M.D.,Ph.D. study director
Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University
Geng Chen, M.D.,Ph.D. principal investigator
Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical 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 Pancreas-sparing duodenectomy and Pancreaticoduodenectomy in people with Periampullary Carcinoma Nos, 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 7 inclusion and 7 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 9 Feb 2011. 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 Geng Chen, M.D.,Ph.D. (86-0-13996418308, chengeng@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: 5 years). 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 9 Feb 2011.