An observational study in Pancreatic Cancer and Periampullary Carcinoma, sponsored by Peking University Third Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-04-05.
Sponsored by Peking University Third Hospital · Observational
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Among 629 studies in Pancreatic Neoplasms with a site in China — 334 open to participants now, 359 under way, 30 of them phase 3. Pancreatic Neoplasms · China.
Among the 629 studies in Pancreatic Neoplasms with a site in China, this one is the 70th largest by planned enrollment of the 121 observational ones that give a count, is one of 19 that started in 2017, is one of 121 observational ones, and was the 96th registered.
3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,005 are open to participants now.
Browse Pancreatic Neoplasms studies →334 of the 629 studies in Pancreatic Neoplasms with a site in China are open now. Recruiting first, the newest first:
Jiangsu HengRui Medicine Co., Ltd. · Sites in China
Ages 18–70
Ningbo Medical Center Lihuili Hospital · Sites in China
Ages 18–85
West China Hospital · Sites in China
Ages 18–75
Genfleet Therapeutics (Shanghai) Inc. · Sites in China
Ages 18–80
Peking University Third Hospital · Sites in China
Ages 18+
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 745 Pancreatic Neoplasms studies recruiting now, 478 (64%) set no upper age limit and 151 (20%) stop at 75 or younger; 40 take children under 18; 59 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
629 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 190 · Phase 2 246 · Phase 3 54 · Phase 4 8
First in 2001; this study’s year is marked. 19 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 120 is below the median of 200 across 740 observational studies indexed under Pancreatic Neoplasms.
Median enrollment 58 across the 507 interventional studies, 220 across the 121 observational. Of the 112 that completed or were terminated, 12 (11%) have results posted.
This tab as a report to print or save as PDF → With an account.
135 of 629 have an industry lead sponsor. The 10 most frequent:
Peking University Third Hospital is the lead sponsor of 755 studies on the registry; 276 are open to participants now.
Peking University Third Hospital has 8 studies filed under Pancreatic Neoplasms — fewer than ten, so there is no comparison to draw.
101 of the studies in Pancreatic Neoplasms with a site in China that are under way reach primary completion within a year, 10 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06601283Phase 3Fudan UniversityVitamin C Plus Cordyceps to Chemotherapy Related Anemia in Pancreatic Cancer | 2026-11-22 |
| NCT05653453Phase 3Jiangsu Healthy Life Innovation Medical Technology Co., LtdClinical Study of Tumor Treating Fields Combined with Gemcitabine and Albumin-bound Paclitaxel in the First-line Treatment of Locally Advanced Pancreatic Cancer | 2026-12-25 |
| NCT06217042Phase 3Fudan UniversityHR070803 in Combination With Oxaliplatin, 5-fluorouracil/LV Versus GX as Adjuvant Therapy for Pancreatic Cancer | 2027-03-30 |
| NCT06953999Phase 3AkesoA Phase III Study of Ivonescimab + Chemo With/Without AK117 in Metastatic Pancreatic Cancer | 2027-05-14 |
| NCT06409429Phase 3Tianjin Medical University Cancer Institute and HospitalNimotuzumab Combined With GX as Postoperative Adjuvant Therapy in Pancreatic Cancer | 2027-05-30 |
Add all 101 to your calendar (.ics) → With an account.
Among the 629 studies in Pancreatic Neoplasms with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
All the patients in the Department of General Surgery, Peking University Third Hospital who match to the eligibility criteria will be selected and recruited
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Shark Mouth Modified Pancreaticojejunostomy is performed following pancreaticoduodenectomy.
Procedure: Shark Mouth Modified Pancreaticojejunostomy
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.
pancreatic fistula
The determine of pancreatic fistula follows the International Study Group on Pancreatic Fistulas (ISGPF) criteria.
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
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
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
any post-operation complications will be recorded and graded according the Clavien-Dindo Classification of Surgical Complications
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
The operation time of pancreaticojejunostomy
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
Post-operation hospital stay will be documented.
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
Plan to share: Yes — All collected individual participant data will be shared.
Supporting information: Study protocol, Clinical study report
Time frame: Stating 12 months after publication
Access criteria: All the global researchers may get all the individual participant data by sending emai to xiudianrong7320@163.com
Started Dec 2017 (actual). Primary completion is estimated for Dec 2019, 24 months after the start.
Of 318 non-industry observational studies under Pancreatic Neoplasms, half reached primary completion within 74 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 182. This study's planned 24 months is below that.
Counting every sponsor, half of 352 studies reached it within 60 months; a quarter within 34 and three quarters within 182.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Peking University Third Hospital →