Pancreatic CancerSMMPNCT03366038
Shark Mouth Modified Pancreaticojejunostomy
An observational study of Pancreatic Cancer and Periampullary Carcinoma, run by Peking University Third Hospital at 1 site in China.
Trial summary
Pancreaticoduodenectomy (PD) is one of the most complicated surgical procedure and one of the standard treatments for benign and malignant disease of pancreatic head and periampullary region. 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?
- Shark Mouth Modified Pancreaticojejunostomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 8 Dec 2017to 1 May 2020
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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
Study population: All the patients in the Department of General Surgery, Peking University Third Hospital who match to the eligibility criteria will be selected and recruited
Who may be able to join
- Patients diagnosed with pancreatic cancer or other diseases which need pancreaticoduodenectomy
- Operation-tolerated
- Informed consent
Who cannot join
- History of abdominal operation
- Pancreaticoduodenectomy is given up during operation
- Patients require to exit from the study anytime
- Pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of General Surgery, Peking University Third Hospital
Beijing, 100191
Wang Hangyan, Doctor, 15611963104, wanghangyan111@163.com
About this study
Official title: Shark Mouth Modified Pancreaticojejunostomy in Pancreaticoduodenectomy Procedure
Pancreaticoduodenectomy (PD) is one of the most complicated surgical procedure and one of the standard treatments for benign and malignant disease of pancreatic head and periampullary region. Improvements in surgical techniques and the perioperative management of patients undergoing PD have reduced the surgical mortality rates to less than 3% in high-volume medical centers. However, the incidence of postoperative complication remains high, which ranges from 30% to 50% and the pancreatic fistula rate ranges from 5% to 40%. The key point of PD is still the enteric reconstruction of pancreatic stump. There were different techniques of enteric reconstruction, including: invagination pancreaticojejunostomy, binding pancreaticojejunostomy, duct-to-mucosa pancreaticojejunostomy, Roux-en-Y pancreaticojejunostomy, and pancreaticogastrostomy and each technique had its advantages and disadvantages. We established a new digestive reconstruction technique named shark mouth modified pancreaticojejunostomy, which had theoretical advantages including easier performed; lower tension and less complication. The shark mouth modified pancreaticojejunostomy is an end-to-end pancreaticojejunostomy procedure which is between invagination pancreaticojejunostomy and binding pancreaticojejunostomy.The remnant of jejunum is shaped as shark mouth and then sutured with the pancreas remnant. After the surgery, the patients will be well followed up. The pancreaticojejunostomy time, post-operation complication, mortality and hospital stay will be documented to study the safety, efficiency and advantage of this new procedure.
Read the detailed description
A pancreaticoduodenectomy (PD) still remains the curable treatment choice for most of malignant and benign neoplasms of the head of the pancreas and periampullary region. Though the safety of PD has been significantly improved, the post-operative pancreatic fistula (POPF) always is a formidable complication. More and more attention was focused on the different procedure of enteric reconstruction of pancreatic stump, which might be the key point to reduce the POPF.
This is a prospective clinical trial performed in the general surgery department of Peking University Third Hospital. All pancreatic remnants are reconstructed with the method of Shark Mouth Modified Pancreaticojejunostomy. Shark Mouth Modified Pancreaticojejunostomy is performed as standardized procedure and all the detailed data of this procedure is documented, including gland texture, pancreas duct diameter, size of the stent, width of the pancreatic stump and diameter of the jejunum transverse incision. Silicone tube is inserted as internal stents and fixed on the pancreas remnant with non-absorbable sutures. The distal end of the tube should exceed the anastomosis of the common bile duct and jejunum. The same perioperative management strategies are conducted in all patients. Drainages are placed in all patients during the surgeries. Prophylactic somatostatin analogue are used in all cases for 3 days post operations.
Theoretically, the incision of "Shark Mouth" might facilitate the pancreaticojejunostomy especially for the large pancreatic remnant; the feature of anastomosis might reduce the tension of pancreaticojejunostomy, which is important for the healing of anastomosis and might reduce the risk of POPF in the soft pancreas; the characters of anastomosis permits total drainage of pancreatic remnant, which is crucial in the situation of thinner pancreatic ducts.The purpose of this study is to evaluate the new anastomosis called "Shark Mouth Modified Pancreaticojejunostomy", especially the morbidity of POPF.
- Conditions
- Pancreatic Cancer, Periampullary Carcinoma
- Being tested
- Shark Mouth Modified Pancreaticojejunostomy
- Keywords
- pancreaticoduodenectomy, pancreaticojejunostomy, pancreatic fistula
- Medical subject headings
- Pancreatic Neoplasms, Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shark Mouth Modified PancreaticojejunostomyProcedure or surgery
The remnant of jejunum is closed by continuous suture. The transverse incision is made on the posterior wall of the jejunum (5 centimeters distal to remnant）, which starts at 0.2 centimeter to the mesenteric border and should never exceed the anti-mesenteric border . In case of large pancreas remnant, a longitudinal jejunum incision will be done at anterior part of anastomosis.
The posterior part of anastomosis is two layers of intermittent suture, including seromuscular suture layer and full thickness suture layer. The anterior part of anastomosis is a single layer full thickness suture. At last, the seromuscular layer of the proximal jejunum is sutured with the anterior pancreatic capsule to cover the anterior part of anastomosis.
| Study group | Role | What they receive |
|---|---|---|
| Modified Pancreaticojejunostomy | Shark Mouth Modified Pancreaticojejunostomy is performed following pancreaticoduodenectomy. Receives: Procedure: Shark Mouth Modified Pancreaticojejunostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pancreatic fistula
The determine of pancreatic fistula follows the International Study Group on Pancreatic Fistulas (ISGPF) criteria.
Measured: From 3 days after operation until the date of discharge or date of drains removal, whichever came first, assessed up to 90 days
Secondary outcomes (4)
Mortality
30-day or in-hospital mortality: death from any cause within 30 days after operation or any in-hospital death are considered concerned with the procedure of pancreaticojejunostomy
Measured: From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 90 days
Morbidity
any post-operation complications will be recorded and graded according the Clavien-Dindo Classification of Surgical Complications
Measured: From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 90 days
pancreaticojejunostomy time
The operation time of pancreaticojejunostomy
Measured: From the start of intraoperative transverse incision on the posterior wall of the jejunum to the finishing of shark mouth modified pancreaticojejunostomy .
Hospital stay
Post-operation hospital stay will be documented.
Measured: From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start8 Dec 2017
- Primary completion9 Dec 2019 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 Peking University Third HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dianrong Xiu, Peking University Third Hospital
- Investigators
- Xiu Dainrong, Doctor, Principal investigator, Department of General Surgery, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03366038
- Sponsor's protocol ID
- PekingUTHGS
- Acronym
- SMMP
- Status last verified
- Apr 2018
- First submitted
- 4 Dec 2017
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected individual participant data will be shared.
Publications
Chen YJ, Lai EC, Lau WY, Chen XP. Enteric reconstruction of pancreatic stump following pancreaticoduodenectomy: a review of the literature. Int J Surg. 2014;12(7):706-11. doi: 10.1016/j.ijsu.2014.05.060. Epub 2014 May 20.
PubMed 24851718Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande SV, Takada T, Takaori K, Traverso W, Vollmer CM, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-591. doi: 10.1016/j.surg.2016.11.014. Epub 2016 Dec 28.
PubMed 28040257Wang HY, Li MX, Xiu DR. Shark mouth pancreaticojejunostomy: a new enteric reconstruction procedure of pancreatic stump. Chin Med J (Engl). 2019 Jun 5;132(11):1354-1358. doi: 10.1097/CM9.0000000000000219.
PubMed 30896569
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shark Mouth Modified Pancreaticojejunostomy in Pancreaticoduodenectomy Procedure
- ClinicalTrials.gov ID
- NCT03366038
- Acronym / sponsor ID
- SMMP / PekingUTHGS
- Conditions
- Pancreatic Cancer, Periampullary Carcinoma
- Keywords
- pancreaticoduodenectomy, pancreaticojejunostomy, pancreatic fistula
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 8 Dec 2017 (actual)
- Primary completion
- 9 Dec 2019 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 8 Dec 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.
Pancreaticoduodenectomy (PD) is one of the most complicated surgical procedure and one of the standard treatments for benign and malignant disease of pancreatic head and periampullary region. Improvements in surgical techniques and the perioperative management of patients undergoing PD have reduced the surgical mortality rates to less than 3% in high-volume medical centers. However, the incidence of postoperative complication remains high, which ranges from 30% to 50% and the pancreatic fistula rate ranges from 5% to 40%. The key point of PD is still the enteric reconstruction of pancreatic stump. There were different techniques of enteric reconstruction, including: invagination pancreaticojejunostomy, binding pancreaticojejunostomy, duct-to-mucosa pancreaticojejunostomy, Roux-en-Y pancreaticojejunostomy, and pancreaticogastrostomy and each technique had its advantages and disadvantages. We established a new digestive reconstruction technique named shark mouth modified pancreaticojejunostomy, which had theoretical advantages including easier performed; lower tension and less complication. The shark mouth modified pancreaticojejunostomy is an end-to-end pancreaticojejunostomy procedure which is between invagination pancreaticojejunostomy and binding pancreaticojejunostomy.The remnant of jejunum is shaped as shark mouth and then sutured with the pancreas remnant. After the surgery, the patients will be well followed up. The pancreaticojejunostomy time, post-operation complication, mortality and hospital stay will be documented to study the safety, efficiency and advantage of this new procedure.
Detailed description
A pancreaticoduodenectomy (PD) still remains the curable treatment choice for most of malignant and benign neoplasms of the head of the pancreas and periampullary region. Though the safety of PD has been significantly improved, the post-operative pancreatic fistula (POPF) always is a formidable complication. More and more attention was focused on the different procedure of enteric reconstruction of pancreatic stump, which might be the key point to reduce the POPF.
This is a prospective clinical trial performed in the general surgery department of Peking University Third Hospital. All pancreatic remnants are reconstructed with the method of Shark Mouth Modified Pancreaticojejunostomy. Shark Mouth Modified Pancreaticojejunostomy is performed as standardized procedure and all the detailed data of this procedure is documented, including gland texture, pancreas duct diameter, size of the stent, width of the pancreatic stump and diameter of the jejunum transverse incision. Silicone tube is inserted as internal stents and fixed on the pancreas remnant with non-absorbable sutures. The distal end of the tube should exceed the anastomosis of the common bile duct and jejunum. The same perioperative management strategies are conducted in all patients. Drainages are placed in all patients during the surgeries. Prophylactic somatostatin analogue are used in all cases for 3 days post operations.
Theoretically, the incision of "Shark Mouth" might facilitate the pancreaticojejunostomy especially for the large pancreatic remnant; the feature of anastomosis might reduce the tension of pancreaticojejunostomy, which is important for the healing of anastomosis and might reduce the risk of POPF in the soft pancreas; the characters of anastomosis permits total drainage of pancreatic remnant, which is crucial in the situation of thinner pancreatic ducts.The purpose of this study is to evaluate the new anastomosis called "Shark Mouth Modified Pancreaticojejunostomy", especially the morbidity of POPF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Modified Pancreaticojejunostomy | – | Procedure: Shark Mouth Modified PancreaticojejunostomyShark Mouth Modified Pancreaticojejunostomy is performed following pancreaticoduodenectomy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the patients in the Department of General Surgery, Peking University Third Hospital who match to the eligibility criteria will be selected and recruited
Key inclusion criteria (3 listed)
- Patients diagnosed with pancreatic cancer or other diseases which need pancreaticoduodenectomy
- Operation-tolerated
- Informed consent
Key exclusion criteria (4 listed)
- History of abdominal operation
- Pancreaticoduodenectomy is given up during operation
- Patients require to exit from the study anytime
- Pregnancy
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 |
|---|---|---|
| Shark Mouth Modified PancreaticojejunostomyThe remnant of jejunum is closed by continuous suture. The transverse incision is made on the posterior wall of the jejunum (5 centimeters distal to remnant）, which starts at 0.2 centimeter to the mesenteric border and should never exceed the anti-mesenteric border . In case of large pancreas remnant, a longitudinal jejunum incision will be done at anterior part of anastomosis. The posterior part of anastomosis is two layers of intermittent suture, including seromuscular suture layer and full thickness suture layer. The anterior part of anastomosis is a single layer full thickness suture. At last, the seromuscular layer of the proximal jejunum is sutured with the anterior pancreatic capsule to cover the anterior part of anastomosis. | Procedure or surgery | Modified Pancreaticojejunostomy |
Primary outcome
pancreatic fistula
Time frame: From 3 days after operation until the date of discharge or date of drains removal, whichever came first, assessed up to 90 days
The determine of pancreatic fistula follows the International Study Group on Pancreatic Fistulas (ISGPF) criteria.
4 secondary outcomes
Mortality
Time frame: From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 90 days
Morbidity
Time frame: From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 90 days
pancreaticojejunostomy time
Time frame: From the start of intraoperative transverse incision on the posterior wall of the jejunum to the finishing of shark mouth modified pancreaticojejunostomy .
Hospital stay
Time frame: From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Background: PubMed 24851718Chen YJ, Lai EC, Lau WY, Chen XP. Enteric reconstruction of pancreatic stump following pancreaticoduodenectomy: a review of the literature. Int J Surg. 2014;12(7):706-11. doi: 10.1016/j.ijsu.2014.05.060. Epub 2014 May 20.
- Background: PubMed 28040257Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande SV, Takada T, Takaori K, Traverso W, Vollmer CM, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-591. doi: 10.1016/j.surg.2016.11.014. Epub 2016 Dec 28.
- Derived from this study: PubMed 30896569Wang HY, Li MX, Xiu DR. Shark mouth pancreaticojejunostomy: a new enteric reconstruction procedure of pancreatic stump. Chin Med J (Engl). 2019 Jun 5;132(11):1354-1358. doi: 10.1097/CM9.0000000000000219.
- Individual participant dataSharing planned: Yes. All collected individual participant data will be shared.
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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.
Xiu Dainrong, Doctor principal investigator
Department of General Surgery, Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and Periampullary Carcinoma, run by Peking University Third Hospital 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 4 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 5 Apr 2018. 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 Wang hangyan, Doctor (15611963104 ext. 01082267328, wanghangyan111@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pancreatic fistula (time frame: From 3 days after operation until the date of discharge or date of drains removal, whichever came first, assessed up to 90 days). 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 NCT03366038, which also lists 3 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 5 Apr 2018.